Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role

Obesity Clinical Trial

— OWL-CGM  

Official title:

Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05890209
• Other study ID #: 200220068
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: October 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

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