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

NCT04564586 | Unknown

• 1 other identifier: IRB#1193356
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Metabolic Syndrome, Protection Against

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Weight Loss

  Weight Loss by % of change and total weight change (kg)

  12 Months

• Physical Activity

  Physical activity days/week, change \> 10% of PA, Kcal/week

  6 months

• Inactivity

  Change in Sedentary Time, Mins/day

  6 months

Secondary Outcomes (2)

• Health Related Quality of Life

  6 months

• Hemoglobin A1c

  12 months

Study Arms (1)

Enhanced Intervention Group (EIG)

OTHER

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

Interventions

DPPFit 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.

Enhanced Intervention Group (EIG)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-institutionalized adult patients
• Ages 18 - 55 years
• Diagnosed as prediabetes or with HbA1c% values between 5.7-6.4%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University - General Internal Medicine Clinic

Augusta, Georgia, 30912, United States

Location

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

  PMID: 28428979 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Jessica L Stewart, MPH

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 25, 2020
• Study Start: January 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)