Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role

NCT05890209 | Active Not Recruiting DMC

• 1 other identifier: 200220068
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Obesity

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Qualitative evaluation of participant's experiences

  24 weeks

• Changes in biomarkers of cardio-metabolic disease risk

  24 weeks

Study Arms (2)

Personalized Weight Management group (PWM)

NO INTERVENTION

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 + Continuous Glucose Monitoring (CGM)

EXPERIMENTAL

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

Interventions

Continuous Glucose Monitoring device 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.

PWM + Continuous Glucose Monitoring (CGM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

University of Glasgow

Glasgow, G128QQ, United Kingdom

Location

MeSH Terms

Conditions

Weight Loss; Obesity

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: June 6, 2023
• Study Start: April 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: October 15, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)