Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role (OWL-CGM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Device: Continuous Glucose Monitoring device

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G128QQ
    • University of Glasgow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥18 years old.
• Intentionally lost ≥5 kg within the past 6 months
• Have a BMI of >25kg/m2 prior to weight loss
• Have access to and be able to use a smartphone or tablet running iOS or Android and be able to use the Freestyle Libre app and MyFood24 app OR access and ability to use a telephone.
• Participants should be willing to use CGM.
• Participants must be able to read, understand and communicate in English

Exclusion Criteria:

• Have been diagnosed with Type 1 and Type 2 Diabetes
• Pregnant or planning pregnancy in the next 6 months, or currently breastfeeding.
• Participants who are currently on any pharmacological treatments for weight loss or any drugs may affect body weight.
• Participants who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy.
• Participants with known hypersensitivity to CGM sensors.
• Participants with any other serious medical condition, in the opinion of the investigators, would compromise their safety or adherence to the study.
• Participants diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or purging disorder).
• Participants who lack capacity or are unable to read or understand written or verbal instructions in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: PWM + Continuous Glucose Monitoring (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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research recruitment rate	The number of adults being recruited over the course of recruitment phase.	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.	24 weeks
Adherence of CGM use	The proportion of days for which valid CGM data are obtained from the CGM group.	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.	24 weeks
Changes in physical activity	Physical Activity level monitored objectively for a day using an accelerometer at 0, 12, 24 weeks.	24 weeks
Changes in weight	Weight will be monitored using weight scale from baseline Week 0, Week 12 and Week 24	24 weeks
Changes in body composition	Body composition will be measured using bioelectrical impedance at Week 0, 12, 24	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	24 weeks

Collaborators and Investigators

• Sponsor: University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 200220068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No