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

Not Applicable

• Conditions: Metabolic Syndrome, Protection Against; PreDiabetes
• Interventions: Behavioral: DPPFit

• Registration Number: NCT04564586
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced Intervention Group (EIG)	DPPFit	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity	6 months	Physical activity days/week, change \> 10% of PA, Kcal/week
Weight Loss	12 Months	Weight Loss by % of change and total weight change (kg)
Inactivity	6 months	Change in Sedentary Time, Mins/day

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c	12 months	Change in % of HbA1c at 1 year follow-up
Health Related Quality of Life	6 months	MOS SF-20 / MOS Social Support Scale

Trial Locations

Locations (1)

Augusta University - General Internal Medicine Clinic; 🇺🇸 Augusta, Georgia, United States