Clinical trial NCT04564586: Developing and Testing a Technology-Based Translation of the DPP to Address Prediabetes in a Primary Care Setting
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
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Metabolic Syndrome, Protection Against
Keywords: mHealth
real-world setting
primary care intervention
diabetes prevention
remote
translation
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight Loss
timeFrame: 12 Months
measure: Physical Activity
timeFrame: 6 months
measure: Inactivity
timeFrame: 6 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 6 months
measure: Hemoglobin A1c
timeFrame: 12 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University - General Internal Medicine Clinic
state: Georgia
Study officials:
affiliation: Augusta University
name: Jessica L Stewart, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.