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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04564586
Acronym
DPPFit
Enrollment
32
Registered
2020-09-25
Start date
2020-01-01
Completion date
2022-10-01
Last updated
2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Protection Against, PreDiabetes

Keywords

mHealth, real-world setting, primary care intervention, diabetes prevention, remote, translation

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.

Interventions

BEHAVIORALDPPFit

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.

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weight Loss12 MonthsWeight Loss by % of change and total weight change (kg)
Physical Activity6 monthsPhysical activity days/week, change \> 10% of PA, Kcal/week
Inactivity6 monthsChange in Sedentary Time, Mins/day

Secondary

MeasureTime frameDescription
Health Related Quality of Life6 monthsMOS SF-20 / MOS Social Support Scale
Hemoglobin A1c12 monthsChange in % of HbA1c at 1 year follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026