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Developing and Testing a Technology-Based Translation of the DPP to Address Prediabetes in a Primary Care Setting (DPPFit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564586
Recruitment Status : Active, not recruiting
First Posted : September 25, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica Lynn Stewart, MPH, Augusta University

Brief Summary:
DPPFit is a Healthy Lifestyle Intervention designed to reformat the effective strategies of the Diabetes Prevention Program (NDPP) into a tool for use in a primary care setting. DPPFit is a 16-week technology-based intervention for diabetes prevention. In keeping with the National DPP educational sessions, the intervention weeks follow the order and presentation of the N-DPP 16 session topics. The goal is to develop a pragmatic translation of the DPP that is effective in the real-world setting of primary care clinic. The hope is that in doing so, those at risk of developing type II diabetes mellitus will have evidenced-based prevention methods at their disposal.

Condition or disease Intervention/treatment Phase
PreDiabetes Metabolic Syndrome, Protection Against Behavioral: DPPFit Not Applicable

Detailed Description:

DPPFit is an HLI designed to translate the effective strategies of the National Diabetes Prevention Program (N-DPP) into a tool for use in a primary care setting. The 16-week intervention follows the order of the 16 sessions that make up the core components of the traditional DPP. The novelty in this application is the intervention delivery, in addition to the use of technology to supplement resource and time intensive DPP behavioral strategies. The entire intervention is delivered through automated text messages (SMS/MMS). For any given week, the daily text messages for that week reflect the core session of the DPP (i.e DPPFit Week 1 texts correspond to DPP Session 1). In addition to the automated daily messages, participants are issued a Fitbit and assisted in setting up the Fitbit App on their smart phones. The Fitbit App is considered a standalone mHealth App. The fitness tracker and companion App allow participants to set goals and track food and physical activity. The content of the text messaging is almost entirely from the N-DPP participant notebook (2012). Exceptions to this are a series of prompts to cue participant to use the Fitbit and/or Fitbit App to support the session. These include topics about setting goals in the Fitbit App, how to track food using the App, or how to connect with friends and do challenges on Fitbit.

To be sustainable and feasible in a primary care setting, remote delivery of intervention materials and components is a necessary part of any evidence-based tool to address diabetes prevention. This automated, remote dissemination, technology-based application of the N-DPP components means that intervention delivery and protocol are feasible methods to address diabetes prevention in light of the ongoing Covid-19 health crisis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing and Testing a Technology-Based Translation of the Diabetes Prevention Program for Adult Primary Care Patients At-Risk of Developing Type 2 Diabetes Mellitus
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Enhanced Intervention Group (EIG)
The Enhanced Intervention Group was a subgroup of the participants that were invited for voluntary weekly meet-n-greet sessions in the Primary Care Clinic. These sessions were information and not educational sessions for the intervention. The entire EIG concept was to test a social component of participants by providing an informal opportunity for a DPPFit social group. The group sessions were terminated after only 5 weeks as a result of the Covid-19 pandemic. They were the only component of the DPPFit study that were face-to-face.
Behavioral: DPPFit
Participants issued Fitbit Device and set up Fitbit App. They are then enrolled in the automated text messaging platform. Day 1 of the intervention begins the Monday after consent. All consented participants receive the full intervention.




Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 12 Months ]
    Weight Loss by % of change and total weight change (kg)

  2. Physical Activity [ Time Frame: 6 months ]
    Physical activity days/week, change > 10% of PA, Kcal/week

  3. Inactivity [ Time Frame: 6 months ]
    Change in Sedentary Time, Mins/day


Secondary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: 6 months ]
    MOS SF-20 / MOS Social Support Scale

  2. Hemoglobin A1c [ Time Frame: 12 months ]
    Change in % of HbA1c at 1 year follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-institutionalized adult patients
  • Ages 18 - 55 years
  • Diagnosed as prediabetes or with HbA1c% values between 5.7-6.4%.

Exclusion Criteria:

  • Prior bariatric surgery
  • Participation in weight loss program or current weight loss medication.
  • History of T1DM or T2DM diagnosis
  • Use of medications to treat glucose intolerance, including biguanides and sulfonylureas.
  • History of infarction, angina, coronary artery bypass graft surgery, coronary angioplasty, congestive heart failure, or any condition that significantly limits their exercise such as peripheral arterial disease.
  • BMI (kg/m²)< 18.5

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): NCT04564586


Locations
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United States, Georgia
Augusta University - General Internal Medicine Clinic
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Jessica L Stewart, MPH Augusta University
Publications:
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Responsible Party: Jessica Lynn Stewart, MPH, Principle Investigator, Augusta University
ClinicalTrials.gov Identifier: NCT04564586    
Other Study ID Numbers: IRB#1193356
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
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 Jessica Lynn Stewart, MPH, Augusta University:
mHealth
real-world setting
primary care intervention
diabetes prevention
remote
translation
Additional relevant MeSH terms:
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Metabolic Syndrome
Prediabetic State
Glucose Intolerance
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia