At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adaptation of a Digital Weight Loss Intervention Promoting Self-regulation for Use in Type 2 Diabetes
In Brief
A clinical study evaluating Behavioral weight loss with digital tools for Diabetes Mellitus, Type 2 and Overweight and Obesity. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.