Evaluation of a Telehealth DPP With Medicare Patients at the University of Mississippi Medical Center

• ClinicalTrials.gov Identifier: NCT04822480
• Recruitment Status: Recruiting
• First Posted: March 30, 2021
• Last Update Posted: January 27, 2022
• Sponsor: University of Mississippi Medical Center
• Collaborators: American Medical Association; Mississippi State Department of Health
• Information provided by (Responsible Party): Abigail Gamble, University of Mississippi Medical Center

Study Description

Brief Summary:

The National Diabetes Prevention Program (DPP) is an evidence-based, 12-month lifestyle change program to prevent or delay the onset of type 2 diabetes mellitus (herein referred to as 'diabetes') among adults with prediabetes. The Department of Preventive Medicine, University of Mississippi Medical Center (UMMC), in partnership with the American Medical Association, is collaborating to develop and implement the DPP as a clinical service for UMMC patients beginning in September 2020. We aim to recruit 245 patients per year over 3 years. Because this is the first attempt to develop and implement the DPP as a clinical service at the UMMC, we are proposing to conduct a comprehensive process, outcome, impact and return on investment evaluation. An effectiveness-implementation hybrid research design will be used to (1) evaluate a multifaceted implementation strategy and the effectiveness and impact of the DPP delivered using telehealth by UMMC's Department of Preventive Medicine; (2) conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and return on investment (ROI) relative to non-participants; (3) conduct a longitudinal cohort analysis to assess incidence of diabetes and changes in body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not.

The findings from this comprehensive research evaluation will be used to (1) improve clinical operations and implementation; (2) demonstrate the cost benefit of the DPP as a clinical service for patients with diabetes risk; and (3) provide empirical support for delivering the DPP via different modalities including telehealth to reduce risk and improve health outcomes among patients.

Condition or disease	Intervention/treatment
PreDiabetes; Prediabetic State	Behavioral: Diabetes Prevention Program (DPP)

Detailed Description:

The purpose of this research is to: (1) Evaluate a multifaceted implementation strategy for the uptake of a remote DPP by UMMC's Department of Preventive Medicine. (2) Conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and ROI relative to non-participants. (3) Conduct a longitudinal cohort analysis to assess incidence of diabetes, body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not. Study methods are described below according to each of three specific aims.

Aim 1: Conduct a concurrent implementation and effectiveness evaluation of the DPP in a clinical care setting for patients with prediabetes (n=245). An effectiveness-implementation hybrid type III research design will be used to conduct a non-randomized trial with 245 of patients with prediabetes over a three year recruitment period, while employing an iterative process evaluation to explore the complex processes, dynamic context and organizational influences on implementation. The RE-AIM framework will guide the implementation and effectiveness evaluation including measures of Reach, Effectiveness, Adoption, Implementation and Maintenance. Multiple data sources and data types will be used to assess barriers and facilitators that affect the RE-AIM domains, as well as fidelity, costs, patient satisfaction and physician burnout.

Aim 2: Utilize claims and encounters data to measure medical expenditures for patients with prediabetes, and determine spending differentials among DPP participants compared with non-DPP participants. Track trends in per capita medical expenditures for among a panel of case (DPP participant) and control (Non-DPP participant) subjects. To compare variations in spending, the differences in the arithmetic means, compound annual growth rates, and propensity score matching models will be implemented to compare case and control subjects. The study may also look at those with prediabetes that are later diagnosed with diabetes and individuals with prediabetes who are not later diagnosed with the condition. These estimates of spending differentials and evidence of DPP participation and engagement rates will help to further enhance the algorithm to estimate the potential cost savings and ROI if diabetes is prevented or delayed in the at-risk population who participate in the DPP.

Aim 3: Assess the longitudinal effect of the DPP on participant changes in cardiovascular disease risk including anthropometric and clinical biomarker and psychosocial health outcomes (N=245). A prospective, repeated measures, experimental cohort design will be used to determine the long-term impact of the DPP on diabetes incidence and cardiovascular disease risk among DPP patient participants.

Study Design

• Study Type: Observational
• Estimated Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Telehealth Diabetes Prevention Program in an Academic Medical Center Setting: Hybrid Type III Trial
• Actual Study Start Date: February 1, 2020
• Estimated Primary Completion Date: January 31, 2026
• Estimated Study Completion Date: December 31, 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
DPP Patients; UMMC Patients with prediabetes or risk for diabetes based on risk parameters referred to and enrolled in the DPP.	Behavioral: Diabetes Prevention Program (DPP); Individuals with prediabetes can mitigate the risks and costs of diabetes by taking preventative action, such as participation in a National Diabetes Prevention Program (DPP). The DPP began as a multisite randomized controlled trial demonstrating the effectiveness and cost-benefit of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying diabetes among prediabetic participants. In 2010, Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP as a targeted approach (high risk populations) and population-based strategy to reduce the incidence of diabetes and diabetes-related healthcare costs. The goal is to achieve modest weight loss (7%) by developing and implementing behavior change skills resulting in lifestyle modifications such as physical activity (150 minutes per week) and dietary and nutritional practices.
Non-DPP Patients; Control matched UMMC patients with prediabetes or risk for diabetes based on risk parameters not enrolled in the DPP.

Outcome Measures

Primary Outcome Measures :

1. Type 2 diabetes mellitus diagnosis [ Time Frame: Change diabetes diagnosis from baseline to 6-months in DPP compared with non-DPP patients ]
   Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
2. Type 2 diabetes mellitus diagnosis [ Time Frame: Change diabetes diagnosis from baseline to 12-months in DPP compared with non-DPP patients ]
   Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
3. Type 2 diabetes mellitus diagnosis [ Time Frame: Change diabetes diagnosis from baseline to 18-months in DPP compared with non-DPP patients ]
   Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
4. Type 2 diabetes mellitus diagnosis [ Time Frame: Change diabetes diagnosis from baseline to 24-months in DPP compared with non-DPP patients ]
   Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
5. Type 2 diabetes mellitus diagnosis [ Time Frame: Change diabetes diagnosis from baseline to 30-months in DPP compared with non-DPP patients ]
   Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
6. Type 2 diabetes mellitus diagnosis [ Time Frame: Change diabetes diagnosis from baseline to 36-months in DPP compared with non-DPP patients ]
   Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
7. Hemoglobin A1c [ Time Frame: Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients ]
   Lab values extracted from electronic health record
8. Hemoglobin A1c [ Time Frame: Change in HbA1c from baseline to 12-months in DPP compared with non-DPP patients ]
   Lab values extracted from electronic health record
9. Hemoglobin A1c [ Time Frame: Change in HbA1c from baseline to 18-months in DPP compared with non-DPP patients ]
   Lab values extracted from electronic health record
10. Hemoglobin A1c [ Time Frame: Change in HbA1c from baseline to 24-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
11. Hemoglobin A1c [ Time Frame: Change in HbA1c from baseline to 30-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
12. Hemoglobin A1c [ Time Frame: Change in HbA1c from baseline to 36-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
13. Fasting plasma glucose [ Time Frame: Change in fasting plasma glucose from baseline to 6-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
14. Fasting plasma glucose [ Time Frame: Change in fasting plasma glucose from baseline to 12-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
15. Fasting plasma glucose [ Time Frame: Change in fasting plasma glucose from baseline to 18-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
16. Fasting plasma glucose [ Time Frame: Change in fasting plasma glucose from baseline to 24-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
17. Fasting plasma glucose [ Time Frame: Change in fasting plasma glucose from baseline to 30-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
18. Fasting plasma glucose [ Time Frame: Change in fasting plasma glucose from baseline to 36-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
19. 2-hour plasma glucose [ Time Frame: Change in 2-hour plasma glucose from baseline to 6-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
20. 2-hour plasma glucose [ Time Frame: Change in 2-hour plasma glucose from baseline to 12-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
21. 2-hour plasma glucose [ Time Frame: Change in 2-hour plasma glucose from baseline to 18-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
22. 2-hour plasma glucose [ Time Frame: Change in 2-hour plasma glucose from baseline to 24-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
23. 2-hour plasma glucose [ Time Frame: Change in 2-hour plasma glucose from baseline to 30-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
24. 2-hour plasma glucose [ Time Frame: Change in 2-hour plasma glucose from baseline to 36-months in DPP compared with non-DPP patients ]
    Lab values extracted from electronic health record
25. Medical encounters [ Time Frame: Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients ]
    Extracted from electronic health record
26. Medical encounters [ Time Frame: Number of medical encounters between baseline and 12-months in DPP compared with non-DPP patients ]
    Extracted from electronic health record
27. Medical encounters [ Time Frame: Number of medical encounters between baseline and 18-months in DPP compared with non-DPP patients ]
    Extracted from electronic health record
28. Medical encounters [ Time Frame: Number of medical encounters between baseline and 24-months in DPP compared with non-DPP patients ]
    Extracted from electronic health record
29. Medical encounters [ Time Frame: Number of medical encounters between baseline and 30-months in DPP compared with non-DPP patients ]
    Extracted from electronic health record
30. Medical encounters [ Time Frame: Number of medical encounters between baseline and 36-months in DPP compared with non-DPP patients ]
    Extracted from electronic health record
31. Medical expenditures [ Time Frame: Medical expenditures from baseline to 6-months in DPP compared with non-DPP patients ]
    Total dollar amount billed per encounter extracted from electronic health record
32. Medical expenditures [ Time Frame: Medical expenditures from baseline to 12-months in DPP compared with non-DPP patients ]
    Total dollar amount billed per encounter extracted from electronic health record
33. Medical expenditures [ Time Frame: Medical expenditures from baseline to 18-months in DPP compared with non-DPP patients ]
    Total dollar amount billed per encounter extracted from electronic health record
34. Medical expenditures [ Time Frame: Medical expenditures from baseline to 24-months in DPP compared with non-DPP patients ]
    Total dollar amount billed per encounter extracted from electronic health record
35. Medical expenditures [ Time Frame: Medical expenditures from baseline to 30-months in DPP compared with non-DPP patients ]
    Total dollar amount billed per encounter extracted from electronic health record
36. Medical expenditures [ Time Frame: Medical expenditures from baseline to 36-months in DPP compared with non-DPP patients ]
    Total dollar amount billed per encounter extracted from electronic health record

Secondary Outcome Measures :

1. Body weight [ Time Frame: Change in body weight from baseline to 6-months ]
   Total body weight measured using Seca mBCA 554
2. Body weight [ Time Frame: Change in body weight from baseline to 12-months ]
   Total body weight measured using Seca mBCA 554
3. Body weight [ Time Frame: Change in body weight from baseline to 24-months ]
   Total body weight measured using Seca mBCA 554
4. Body weight [ Time Frame: Change in body weight from baseline to 36-months ]
   Total body weight measured using Seca mBCA 554
5. Fat mass [ Time Frame: Change in fat mass from baseline to 6-months ]
   Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
6. Fat mass [ Time Frame: Change in fat mass from baseline to 12-months ]
   Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
7. Fat mass [ Time Frame: Change in fat mass from baseline to 24-months ]
   Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
8. Fat mass [ Time Frame: Change in fat mass from baseline to 36-months ]
   Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
9. Visceral fat [ Time Frame: Change in visceral fat from baseline to 6-months ]
   Visceral fat measured using Seca mBCA 554; bioimpedance analysis
10. Visceral fat [ Time Frame: Change in visceral fat from baseline to 12-months ]
    Visceral fat measured using Seca mBCA 554; bioimpedance analysis
11. Visceral fat [ Time Frame: Change in visceral fat from baseline to 24-months ]
    Visceral fat measured using Seca mBCA 554; bioimpedance analysis
12. Visceral fat [ Time Frame: Change in visceral fat from baseline to 36-months ]
    Visceral fat measured using Seca mBCA 554; bioimpedance analysis
13. Skeletal muscle mass [ Time Frame: Change in skeletal muscle mass from baseline to 6-months ]
    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis
14. Skeletal muscle mass [ Time Frame: Change in skeletal muscle mass from baseline to 12-months ]
    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis
15. Skeletal muscle mass [ Time Frame: Change in skeletal muscle mass from baseline to 24-months ]
    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis
16. Skeletal muscle mass [ Time Frame: Change in skeletal muscle mass from baseline to 36-months ]
    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis
17. Waist circumference [ Time Frame: Change in waist circumference from baseline to 6-months ]
    Measures using Seca 203 circumference measuring tape
18. Waist circumference [ Time Frame: Change in waist circumference from baseline to 12-months ]
    Measures using Seca 203 circumference measuring tape
19. Waist circumference [ Time Frame: Change in waist circumference from baseline to 24-months ]
    Measures using Seca 203 circumference measuring tape
20. Waist circumference [ Time Frame: Change in waist circumference from baseline to 36-months ]
    Measures using Seca 203 circumference measuring tape
21. Systolic blood pressure [ Time Frame: Change in systolic blood pressure from baseline to 6-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
22. Systolic blood pressure [ Time Frame: Change in systolic blood pressure from baseline to 12-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
23. Systolic blood pressure [ Time Frame: Change in systolic blood pressure from baseline to 24-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
24. Systolic blood pressure [ Time Frame: Change in systolic blood pressure from baseline to 36-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
25. Diastolic blood pressure [ Time Frame: Change in diastolic blood pressure from baseline to 6-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
26. Diastolic blood pressure [ Time Frame: Change in diastolic blood pressure from baseline to 12-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
27. Diastolic blood pressure [ Time Frame: Change in diastolic blood pressure from baseline to 24-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
28. Diastolic blood pressure [ Time Frame: Change in diastolic blood pressure from baseline to 36-months ]
    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
29. Resting heart rate [ Time Frame: Change in resting heart rate from baseline to 6-months ]
    Welch Allyn blood pressure unit.
30. Resting heart rate [ Time Frame: Change in resting heart rate from baseline to 12-months ]
    Welch Allyn blood pressure unit.
31. Resting heart rate [ Time Frame: Change in resting heart rate from baseline to 24-months ]
    Welch Allyn blood pressure unit.
32. Resting heart rate [ Time Frame: Change in resting heart rate from baseline to 36-months ]
    Welch Allyn blood pressure unit.
33. Total cholesterol [ Time Frame: Change in total cholesterol from baseline to 6-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
34. Total cholesterol [ Time Frame: Change in total cholesterol from baseline to 12-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
35. Total cholesterol [ Time Frame: Change in total cholesterol from baseline to 24-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
36. Total cholesterol [ Time Frame: Change in total cholesterol from baseline to 36-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
37. HDL cholesterol [ Time Frame: Change in HDL cholesterol from baseline to 6-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
38. HDL cholesterol [ Time Frame: Change in HDL cholesterol from baseline to 12-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
39. HDL cholesterol [ Time Frame: Change in HDL cholesterol from baseline to 24-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
40. HDL cholesterol [ Time Frame: Change in HDL cholesterol from baseline to 36-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
41. Triglycerides [ Time Frame: Change in triglycerides from baseline to 6-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
42. Triglycerides [ Time Frame: Change in triglycerides from baseline to 12-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
43. Triglycerides [ Time Frame: Change in triglycerides from baseline to 24-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
44. Triglycerides [ Time Frame: Change in triglycerides from baseline to 36-months ]
    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
45. Hemoglobin A1c (point of care) [ Time Frame: Change in HbA1c from baseline to 6-months ]
    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
46. Hemoglobin A1c (point of care) [ Time Frame: Change in HbA1c from baseline to 12-months ]
    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
47. Hemoglobin A1c (point of care) [ Time Frame: Change in HbA1c from baseline to 24-months ]
    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
48. Hemoglobin A1c (point of care) [ Time Frame: Change in HbA1c from baseline to 36-months ]
    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
49. Self-efficacy for weight loss and maintenance [ Time Frame: Change in self-efficacy from baseline to 6-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991
50. Self-efficacy for weight loss and maintenance [ Time Frame: Change in self-efficacy from baseline to 12-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991
51. Self-efficacy for weight loss and maintenance [ Time Frame: Change in self-efficacy from baseline to 24-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991
52. Self-efficacy for weight loss and maintenance [ Time Frame: Change in self-efficacy from baseline to 36-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991
53. Readiness to change, stage of change [ Time Frame: Change in stage of change from baseline to 6-months ]
    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009
54. Readiness to change, stage of change [ Time Frame: Change in stage of change from baseline to 12-months ]
    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009
55. Readiness to change, stage of change [ Time Frame: Change in stage of change from baseline to 24-months ]
    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009
56. Readiness to change, stage of change [ Time Frame: Change in stage of change from baseline to 36-months ]
    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009
57. Readiness to change, processes of change [ Time Frame: Change in processes of change from baseline to 6-months ]
    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011
58. Readiness to change, processes of change [ Time Frame: Change in processes of change from baseline to 12-months ]
    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011
59. Readiness to change, processes of change [ Time Frame: Change in processes of change from baseline to 24-months ]
    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011
60. Readiness to change, processes of change [ Time Frame: Change in processes of change from baseline to 36-months ]
    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011
61. Decisional balance [ Time Frame: Change in decisional balance from baseline to 6-months ]
    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988
62. Decisional balance [ Time Frame: Change in decisional balance from baseline to 12-months ]
    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988
63. Decisional balance [ Time Frame: Change in decisional balance from baseline to 24-months ]
    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988
64. Decisional balance [ Time Frame: Change in decisional balance from baseline to 36-months ]
    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988
65. Self-efficacy for overcoming barriers to physical activity and healthy eating [ Time Frame: Change in barrier self-efficacy from baseline to 6-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018
66. Self-efficacy for overcoming barriers to physical activity and healthy eating [ Time Frame: Change in barrier self-efficacy from baseline to 12-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018
67. Self-efficacy for overcoming barriers to physical activity and healthy eating [ Time Frame: Change in barrier self-efficacy from baseline to 24-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018
68. Self-efficacy for overcoming barriers to physical activity and healthy eating [ Time Frame: Change in barrier self-efficacy from baseline to 36-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018
69. Self-regulation of eating behaviors [ Time Frame: Change in self-regulation of eating behaviors from baseline to 6-months ]
    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016
70. Self-regulation of eating behaviors [ Time Frame: Change in self-regulation of eating behaviors from baseline to 12-months ]
    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016
71. Self-regulation of eating behaviors [ Time Frame: Change in self-regulation of eating behaviors from baseline to 24-months ]
    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016
72. Self-regulation of eating behaviors [ Time Frame: Change in self-regulation of eating behaviors from baseline to 36-months ]
    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016
73. Self-regulation of physical activity - goals [ Time Frame: Change in self-regulation of physical activity goals from baseline to 6-months ]
    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
74. Self-regulation of physical activity - goals [ Time Frame: Change in self-regulation of physical activity goals from baseline to 12-months ]
    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
75. Self-regulation of physical activity - goals [ Time Frame: Change in self-regulation of physical activity goals from baseline to 24-months ]
    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
76. Self-regulation of physical activity - goals [ Time Frame: Change in self-regulation of physical activity goals from baseline to 36-months ]
    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
77. Self-regulation of physical activity - planning [ Time Frame: Change in self-regulation of physical activity planning from baseline to 6-months ]
    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
78. Self-regulation of physical activity - planning [ Time Frame: Change in self-regulation of physical activity planning from baseline to 12-months ]
    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
79. Self-regulation of physical activity - planning [ Time Frame: Change in self-regulation of physical activity planning from baseline to 24-months ]
    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
80. Self-regulation of physical activity - planning [ Time Frame: Change in self-regulation of physical activity planning from baseline to 36-months ]
    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002
81. Social support from friends - eating [ Time Frame: Change in social support from baseline to 6-months ]
    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
82. Social support from friends - eating [ Time Frame: Change in social support from baseline to 12-months ]
    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
83. Social support from friends - eating [ Time Frame: Change in social support from baseline to 24-months ]
    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
84. Social support from friends - eating [ Time Frame: Change in social support from baseline to 36-months ]
    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
85. Social support from family - eating [ Time Frame: Change in social support from baseline to 6-months ]
    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
86. Social support from family - eating [ Time Frame: Change in social support from baseline to 12-months ]
    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
87. Social support from family - eating [ Time Frame: Change in social support from baseline to 24-months ]
    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
88. Social support from family - eating [ Time Frame: Change in social support from baseline to 36-months ]
    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
89. Social support from friend - physical activity [ Time Frame: Change in social support from baseline to 6-months ]
    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
90. Social support from friend - physical activity [ Time Frame: Change in social support from baseline to 12-months ]
    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
91. Social support from friend - physical activity [ Time Frame: Change in social support from baseline to 24-months ]
    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
92. Social support from friend - physical activity [ Time Frame: Change in social support from baseline to 36-months ]
    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
93. Social support from family - physical activity [ Time Frame: Change in social support from baseline to 6-months ]
    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
94. Social support from family - physical activity [ Time Frame: Change in social support from baseline to 12-months ]
    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
95. Social support from family - physical activity [ Time Frame: Change in social support from baseline to 24-months ]
    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
96. Social support from family - physical activity [ Time Frame: Change in social support from baseline to 36-months ]
    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987
97. Outcome expectancies [ Time Frame: Change in outcome expectancies from baseline to 6-months ]
    Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018
98. Outcome expectancies [ Time Frame: Change in outcome expectancies from baseline to 12-months ]
    Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018
99. Outcome expectancies [ Time Frame: Change in outcome expectancies from baseline to 24-months ]
    Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018
100. Outcome expectancies [ Time Frame: Change in outcome expectancies from baseline to 36-months ]
     Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018
101. Coping self-efficacy [ Time Frame: Change in coping self-efficacy from baseline to 6-months ]
     Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018
102. Coping self-efficacy [ Time Frame: Change in coping self-efficacy from baseline to 12-months ]
     Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018
103. Coping self-efficacy [ Time Frame: Change in coping self-efficacy from baseline to 24-months ]
     Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018
104. Coping self-efficacy [ Time Frame: Change in coping self-efficacy from baseline to 36-months ]
     Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018

Other Outcome Measures:

1. Eligible DPP patients (reach) [ Time Frame: Baseline to 3-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
2. Eligible DPP patients (reach) [ Time Frame: Baseline to 6-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
3. Eligible DPP patients (reach) [ Time Frame: Baseline to 9-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
4. Eligible DPP patients (reach) [ Time Frame: Baseline to 12-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
5. Eligible DPP patients (reach) [ Time Frame: Baseline to 15-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
6. Eligible DPP patients (reach) [ Time Frame: Baseline to 18-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
7. Eligible DPP patients (reach) [ Time Frame: Baseline to 21-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
8. Eligible DPP patients (reach) [ Time Frame: Baseline to 24-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
9. Eligible DPP patients (reach) [ Time Frame: Baseline to 27-months ]
   Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
10. Eligible DPP patients (reach) [ Time Frame: Baseline to 30-months ]
    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
11. Eligible DPP patients (reach) [ Time Frame: Baseline to 33-months ]
    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record
12. Patients eligible for DPP (reach) [ Time Frame: Baseline to 36-months ]
    Total number of patients in the ambulatory setting eligible for DPP; electronic health record
13. Patients referred to DPP (reach) [ Time Frame: Baseline to 3-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
14. Patients referred to DPP (reach) [ Time Frame: Baseline to 6-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
15. Patients referred to DPP (reach) [ Time Frame: Baseline to 9-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
16. Patients referred to DPP (reach) [ Time Frame: Baseline to 12-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
17. Patients referred to DPP (reach) [ Time Frame: Baseline to 15-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
18. Patients referred to DPP (reach) [ Time Frame: Baseline to 18-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
19. Patients referred to DPP (reach) [ Time Frame: Baseline to 21-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
20. Patients referred to DPP (reach) [ Time Frame: Baseline to 24-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
21. Patients referred to DPP (reach) [ Time Frame: Baseline to 27-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
22. Patients referred to DPP (reach) [ Time Frame: Baseline to 30-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
23. Patients referred to DPP (reach) [ Time Frame: Baseline to 33-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
24. Patients referred to DPP (reach) [ Time Frame: Baseline to 36-months ]
    Total number of patients in the ambulatory setting referred to DPP; electronic health record
25. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 3-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
26. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 6-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
27. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 9-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
28. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 12-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
29. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 15-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
30. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 18-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
31. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 21-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
32. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 24-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
33. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 27-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
34. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 30-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
35. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 33-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
36. Patients enrolled in DPP (reach) [ Time Frame: Baseline to 36-months ]
    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record
37. Referring clinical sites (adoption) [ Time Frame: Baseline to 3-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
38. Referring clinical sites (adoption) [ Time Frame: Baseline to 6-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
39. Referring clinical sites (adoption) [ Time Frame: Baseline to 9-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
40. Referring clinical sites (adoption) [ Time Frame: Baseline to 12-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
41. Referring clinical sites (adoption) [ Time Frame: Baseline to 15-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
42. Referring clinical sites (adoption) [ Time Frame: Baseline to 18-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
43. Referring clinical sites (adoption) [ Time Frame: Baseline to 21-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
44. Referring clinical sites (adoption) [ Time Frame: Baseline to 24-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
45. Referring clinical sites (adoption) [ Time Frame: Baseline to 27-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
46. Referring clinical sites (adoption) [ Time Frame: Baseline to 30-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
47. Referring clinical sites (adoption) [ Time Frame: Baseline to 33-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
48. Referring clinical sites (adoption) [ Time Frame: Baseline to 36-months ]
    Total number of clinical sites referring patients to the DPP, electronic health record
49. Referring providers (adoption) [ Time Frame: Baseline to 3-months ]
    Total number of providers referring patients to the DPP; electronic health record
50. Referring providers (adoption) [ Time Frame: Baseline to 6-months ]
    Total number of providers referring patients to the DPP; electronic health record
51. Referring providers (adoption) [ Time Frame: Baseline to 9-months ]
    Total number of providers referring patients to the DPP; electronic health record
52. Referring providers (adoption) [ Time Frame: Baseline to 12-months ]
    Total number of providers referring patients to the DPP; electronic health record
53. Referring providers (adoption) [ Time Frame: Baseline to 15-months ]
    Total number of providers referring patients to the DPP; electronic health record
54. Referring providers (adoption) [ Time Frame: Baseline to 18-months ]
    Total number of providers referring patients to the DPP; electronic health record
55. Referring providers (adoption) [ Time Frame: Baseline to 21-months ]
    Total number of providers referring patients to the DPP; electronic health record
56. Referring providers (adoption) [ Time Frame: Baseline to 24-months ]
    Total number of providers referring patients to the DPP; electronic health record
57. Referring providers (adoption) [ Time Frame: Baseline to 27-months ]
    Total number of providers referring patients to the DPP; electronic health record
58. Referring providers (adoption) [ Time Frame: Baseline to 30-months ]
    Total number of providers referring patients to the DPP; electronic health record
59. Referring providers (adoption) [ Time Frame: Baseline to 33-months ]
    Total number of providers referring patients to the DPP; electronic health record
60. Referring providers (adoption) [ Time Frame: Baseline to 36-months ]
    Total number of providers referring patients to the DPP; electronic health record
61. Implementation [ Time Frame: Continuous processual evaluation ]
    Qualitative assessment of implementation processes

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Mississippi consistently has among the highest rates of diabetes (14.3%) and prediabetes (36.5%) nationally and is the only state where every county (82 counties) are represented in the Diabetes Belt, a geographic region of the U.S. where the prevalence of diagnosed diabetes is highest. Mississippi has the fourth largest rural population (51.2%) and the highest state percent Black (37.8%) population in the U.S., and has persistently high rates of poverty (20.8%).

Criteria

Inclusion Criteria:

• UMMC patient within the previous 3-years (at least one UMMC clinical visit within the previous 3-years)
• ≥ 18 years AND
• Clinical diagnosis for prediabetes (R73.03)

OR any of the following combinations:

• BMI ≥25 (non-Asian) OR
• BMI ≥23 (Asian) AND
• HbA1c 5.7 - 6.4 percent within the past 12-months OR
• Fasting plasma glucose 110 - 125 mg/dL within the past 12-months OR
• 2-hour plasma glucose 140 - 199 mg/dL within the past 12-months

Exclusion Criteria:

• Pregnant or planning to become pregnant within the next 12 months
• <18 years
• Primary or secondary diagnosis of diabetes mellitus (all codes with prefix of 250 and 249) and other conditions associated with diabetes (357.2, all codes with prefix 362, 366.41, and all codes with prefix 648).
• End stage renal disease

Contacts and Locations

Contacts

Contact: Abigail Gamble, PhD, MS; 601-815-9065; agamble2@umc.edu

Contact: Brea Cole, MS; cbcole@umc.edu

Locations

United States, Mississippi

University of Mississippi Medical Center; Recruiting

Jackson, Mississippi, United States, 39216

Contact: Mary Smith 601-984-2746 mmanuel2@umc.edu

Contact: Brea Cole 601-815-8339 cbcole@umc.edu

Principal Investigator: Abigail Gamble, PhD, MS

Sponsors and Collaborators

University of Mississippi Medical Center

American Medical Association

Mississippi State Department of Health

Investigators

• Principal Investigator: Abigail Gamble, PhD, MS; University of Mississippi Medical Center
• Principal Investigator: Tamkeen Khan, PhD; American Medical Association

More Information

• Responsible Party: Abigail Gamble, Assistant Professor of Preventive Medicine and Population Health Science, University of Mississippi Medical Center
• ClinicalTrials.gov Identifier: NCT04822480
• Other Study ID Numbers: 2020V0327
• First Posted: March 30, 2021
• Last Update Posted: January 27, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abigail Gamble, University of Mississippi Medical Center:

diabetes prevention

Additional relevant MeSH terms:

Prediabetic State; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases