Developing and Testing a Technology-Based Translation of the DPP to Address Prediabetes in a Primary Care Setting (DPPFit)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04564586|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2020
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes Metabolic Syndrome, Protection Against||Behavioral: DPPFit||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||January 1, 2020|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||February 15, 2021|
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.
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.
- Weight Loss [ Time Frame: 12 Months ]Weight Loss by % of change and total weight change (kg)
- Physical Activity [ Time Frame: 6 months ]Physical activity days/week, change > 10% of PA, Kcal/week
- Inactivity [ Time Frame: 6 months ]Change in Sedentary Time, Mins/day
- Health Related Quality of Life [ Time Frame: 6 months ]MOS SF-20 / MOS Social Support Scale
- Hemoglobin A1c [ Time Frame: 12 months ]Change in % of HbA1c at 1 year follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564586
|United States, Georgia|
|Augusta University - General Internal Medicine Clinic|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Jessica L Stewart, MPH||Augusta University|