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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
49
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.
University of Glasgow
Glasgow, United Kingdom
Research recruitment rate
The number of adults being recruited over the course of recruitment phase.
Time frame: 24 weeks
Research retention rate
Retention is the number of participants that remain till the end of the trial at the end of 24 weeks.
Time frame: 24 weeks
Adherence of CGM use
The proportion of days for which valid CGM data are obtained from the CGM group.
Time frame: 24 weeks
Changes in dietary intake
Dietary Intake monitored for 3 days at 0, 12, 24 weeks using the MyFood24 online diaries where the participants will have to log their daily dietary intake.
Time frame: 24 weeks
Changes in physical activity
Physical Activity level monitored objectively for a day using an accelerometer at 0, 12, 24 weeks.
Time frame: 24 weeks
Changes in weight
Weight will be monitored using weight scale from baseline Week 0, Week 12 and Week 24
Time frame: 24 weeks
Changes in body composition
Body composition will be measured using bioelectrical impedance at Week 0, 12, 24
Time frame: 24 weeks
Qualitative evaluation of participant's experiences
Qualitative evaluation of participant's experiences will be conducted through a semi structured interview with 8-12 of participants
Time frame: 24 weeks
Changes in biomarkers of cardio-metabolic disease risk
Biomarkers measurement will be measured at the 0, 12, 24 weeks. The blood will be taken from the participant to test on biomarkers of cardio-metabolic risk which include Fasting insulin level, fasting glucose, triglyceride, cholesterol
Time frame: 24 weeks
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