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

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

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation and Return-on-Investment of a Telehealth Diabetes Prevention Program at the University of Mississippi Medical Center
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.



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 [ Time Frame: Change in self-efficacy from baseline to 6-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items; Clark et al., 1991

  50. Self-efficacy [ Time Frame: Change in self-efficacy from baseline to 12-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items; Clark et al., 1991

  51. Self-efficacy [ Time Frame: Change in self-efficacy from baseline to 24-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items; Clark et al., 1991

  52. Self-efficacy [ Time Frame: Change in self-efficacy from baseline to 36-months ]
    Weight self-efficacy lifestyle questionnaire; 20 items; 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 questionnaire (S-weight); 5 items; 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 questionnaire (S-weight); 5 items; 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 questionnaire (S-weight); 5 items; 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 questionnaire (S-weight); 5 items; 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 questionnaire (P-weight); 34 items; 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 questionnaire (P-weight); 34 items; 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 questionnaire (P-weight); 34 items; 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 questionnaire (P-weight); 34 items; Andres et al., 2011

  61. Decisional balance [ Time Frame: Change in decisional balance from baseline to 6-months ]
    Decisional balance inventory; 20 items; O'Connell and Velicer, 1988

  62. Decisional balance [ Time Frame: Change in decisional balance from baseline to 12-months ]
    Decisional balance inventory; 20 items; O'Connell and Velicer, 1988

  63. Decisional balance [ Time Frame: Change in decisional balance from baseline to 24-months ]
    Decisional balance inventory; 20 items; O'Connell and Velicer, 1988

  64. Decisional balance [ Time Frame: Change in decisional balance from baseline to 36-months ]
    Decisional balance inventory; 20 items; O'Connell and Velicer, 1988

  65. Barrier self-efficacy [ Time Frame: Change in barrier self-efficacy from baseline to 6-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items; Huttunen-Lenz et al., 2018

  66. Barrier self-efficacy [ Time Frame: Change in barrier self-efficacy from baseline to 12-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items; Huttunen-Lenz et al., 2018

  67. Barrier self-efficacy [ Time Frame: Change in barrier self-efficacy from baseline to 24-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items; Huttunen-Lenz et al., 2018

  68. Barrier self-efficacy [ Time Frame: Change in barrier self-efficacy from baseline to 36-months ]
    Self-efficacy for overcoming barriers to physical activity and diet; 10 items; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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; 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 healthy eating scale; 5 items; 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 healthy eating scale; 5 items; 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 healthy eating scale; 5 items; 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 healthy eating scale; 5 items; 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 healthy eating scale; 15 items; 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 healthy eating scale; 15 items; 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 healthy eating scale; 15 items; 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 healthy eating scale; 15 items; 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; 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; 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; 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; 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; 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; 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; 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; 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822480


Contacts
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Contact: Abigail Gamble, PhD, MS 601-815-9065 agamble2@umc.edu
Contact: Mary Smith 601-984-2746 mmanuel2@umc.edu

Locations
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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
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Principal Investigator: Abigail Gamble, PhD, MS University of Mississippi Medical Center
Principal Investigator: Tamkeen Khan, PhD American Medical Association
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Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT04822480    
Other Study ID Numbers: 2020V0327
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Mississippi Medical Center:
diabetes prevention
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases