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Adaptation of a Digital Weight Loss Intervention Promoting Self-regulation for Use in Type 2 Diabetes

NCT03650088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-01-13

Study results available
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Summary

The purpose of this study is to 1) adapt a weight loss app that the Tate team has previously developed to promote PA and diet and adapt them to the needs and perspectives of those with Type 2 Diabetes (T2DM), integrate daily monitoring of BG using continuous monitoring (CGM) and self-monitoring of diet using the simplified system, and develop appropriate displays of data to facilitate comprehension and decision making, 2) develop the modified intervention and, 3) conduct a pilot and feasibility study on short-term impacts of the intervention in overweight adult patients with T2DM not treated with medications in preparation for an R01 submission.

Conditions

  • Diabetes Mellitus, Type 2
  • Overweight and Obesity

Interventions

BEHAVIORAL

Behavioral weight loss with digital tools

Participants will monitor their diet in a study smart phone app using a 'traffic light' approach where foods are categorized as red (high fat and/or calorie), yellow (moderate fat/calorie, high nutrient), or green (low fat/calorie, high nutrient) and adhere to a red food limit recommendation, weigh daily on a digital scale whose data syncs to the study app, gradually increase physical activity and track it using a wearable device for which data is also synced to the app, and monitor blood glucose using Continuous Glucose Monitoring. Participants will meet weekly with a trained interventionist for behavioral lessons (adapted from Diabetes Prevention Program curriculum) and counseling.

Sponsors & Collaborators

Principal Investigators

  • Deborah F. Tate, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-20
Primary Completion
2021-02-26
Completion
2021-02-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650088 on ClinicalTrials.gov