Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890209
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-04-28
Brief Title:
Optimizing Weight Loss Can Continuous Glucose Monitoring Play a Role
Sponsor:
University of Glasgow
Organization:
University of Glasgow
Study Overview
Official Title:
Optimizing Weight Loss Can Continuous Glucose Monitoring Play a Role
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OWL-CGM
Brief 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
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 eg 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 eg 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
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 eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None