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

Primary Purpose

Weight Loss, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Continuous Glucose Monitoring device
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of GlasgowRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Personalized Weight Management group (PWM)

PWM + Continuous Glucose Monitoring (CGM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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, HbA1c, triglyceride, cholesterol

Full Information

First Posted
April 28, 2023
Last Updated
May 25, 2023
Sponsor
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT05890209
Brief Title
Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role
Acronym
OWL-CGM
Official Title
Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Weight Management group (PWM)
Arm Type
No Intervention
Arm Description
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.
Arm Title
PWM + Continuous Glucose Monitoring (CGM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Research recruitment rate
Description
The number of adults being recruited over the course of recruitment phase.
Time Frame
24 weeks
Title
Research retention rate
Description
Retention is the number of participants that remain till the end of the trial at the end of 24 weeks.
Time Frame
24 weeks
Title
Adherence of CGM use
Description
The proportion of days for which valid CGM data are obtained from the CGM group.
Time Frame
24 weeks
Title
Changes in dietary intake
Description
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
Title
Changes in physical activity
Description
Physical Activity level monitored objectively for a day using an accelerometer at 0, 12, 24 weeks.
Time Frame
24 weeks
Title
Changes in weight
Description
Weight will be monitored using weight scale from baseline Week 0, Week 12 and Week 24
Time Frame
24 weeks
Title
Changes in body composition
Description
Body composition will be measured using bioelectrical impedance at Week 0, 12, 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Qualitative evaluation of participant's experiences
Description
Qualitative evaluation of participant's experiences will be conducted through a semi structured interview with 8-12 of participants
Time Frame
24 weeks
Title
Changes in biomarkers of cardio-metabolic disease risk
Description
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, HbA1c, triglyceride, cholesterol
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
ZIP/Postal Code
G128QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurul Hatta
Phone
+447546938511
Email
n.hatta.1@research.gla.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role

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