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

NCT ID: NCT04564586

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-10-01

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.

Conditions

PreDiabetes; Metabolic Syndrome, Protection Against

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

DPPFit

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Jessica Lynn Stewart, PhD, MPH

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica L Stewart, MPH

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Augusta University - General Internal Medicine Clinic

Augusta, Georgia, United States

Countries

United States

References

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):10.15436/2378-6841.16.1123. doi: 10.15436/2378-6841.16.1123. Epub 2016 Nov 30.

Reference Type: BACKGROUND

PMID: 28428979 (View on PubMed)

Other Identifiers

IRB#1193356

Identifier Type: -

Identifier Source: org_study_id