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

Sponsor

Augusta University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04564586

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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