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

Primary Purpose

PreDiabetes, Metabolic Syndrome, Protection Against

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DPPFit
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring mHealth, real-world setting, primary care intervention, diabetes prevention, remote, translation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Augusta University - General Internal Medicine Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Enhanced Intervention Group (EIG)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2020
Last Updated
August 31, 2021
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT04564586
Brief Title
Developing and Testing a Technology-Based Translation of the DPP to Address Prediabetes in a Primary Care Setting
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Metabolic Syndrome, Protection Against
Keywords
mHealth, real-world setting, primary care intervention, diabetes prevention, remote, translation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Intervention Group (EIG)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DPPFit
Intervention Description
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 Measure Information:
Title
Weight Loss
Description
Weight Loss by % of change and total weight change (kg)
Time Frame
12 Months
Title
Physical Activity
Description
Physical activity days/week, change > 10% of PA, Kcal/week
Time Frame
6 months
Title
Inactivity
Description
Change in Sedentary Time, Mins/day
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
MOS SF-20 / MOS Social Support Scale
Time Frame
6 months
Title
Hemoglobin A1c
Description
Change in % of HbA1c at 1 year follow-up
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Stewart, MPH
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University - General Internal Medicine Clinic
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28428979
Citation
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.
Results Reference
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Developing and Testing a Technology-Based Translation of the DPP to Address Prediabetes in a Primary Care Setting

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