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

PreDiabetes Clinical Trial

— DPPFit  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04564586
• Other study ID #: IRB#1193356
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2021
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Syndrome
• Metabolic Syndrome, Protection Against
• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Augusta University - General Internal Medicine Clinic	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Coughlin SS, Stewart J. Use of Consumer Wearable Devices to Promote Physical Activity: A Review of Health Intervention Studies. J Environ Health Sci. 2016 Nov;2(6). doi: 10.15436/2378-6841.16.1123. Epub 2016 Nov 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Weight Loss by % of change and total weight change (kg)	12 Months
Primary	Physical Activity	Physical activity days/week, change > 10% of PA, Kcal/week	6 months
Primary	Inactivity	Change in Sedentary Time, Mins/day	6 months
Secondary	Health Related Quality of Life	MOS SF-20 / MOS Social Support Scale	6 months
Secondary	Hemoglobin A1c	Change in % of HbA1c at 1 year follow-up	12 months