NCT05890209

Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Glasgow · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to determine the potential effectiveness of adding Continuous Glucose Monitoring to a personalized weight loss maintenance program in improving weight loss maintenance. The main questions it aims to answer are: * What is the feasibility and acceptability of wearing a continuous glucose monitoring device in people maintaining weight loss? * Is using continuous glucose monitoring will help to change the food and physical activity behavior in people maintaining weight loss? Participants will be randomized into control and intervention groups where the researchers will compare the effects of wearing continuous glucose monitoring devices on behavior change in both groups.

Detailed description

The study is a 24-week study conducted at the University of Glasgow. It is a randomized, non-blinded, feasibility trial with 48 adults randomized into one of two groups (24 adults in each group): * Personalized Weight Management Group (PWM): The group will receive a personalized diet and physical activity plan and five one-to-one online support meetings with a trained dietitian over the first 12 weeks of the program (in weeks 1, 2, 4, 8, and 12). The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, and physical activity). Participants will be asked to self-manage during weeks 12 - 24 and asked to maintain the diet, PA recommendations, and monitoring based on the advice and training provided in the first 12 weeks of the program. * PWM + CGM: This group will receive the same support as the PWM group. The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, physical activity, and glucose level). In addition, participants will be provided with a CGM device and guidance on how to use this to support weight loss maintenance. They will be provided with CGM devices for the whole study duration.

Conditions

• Weight Loss
• Obesity

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring device	A small wearable transdermal sensor that tracks glucose levels in interstitial fluid by taking measurements at regular and frequent intervals throughout the day and night.

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-07-15
• Completion: 2024-10-15
• First posted: 2023-06-06
• Last updated: 2024-05-16

Locations

1 site across 1 country: United Kingdom