The Impact of CGM on Weight Reduction

NCT07026903 | Completed

• 1 other identifier: 84
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized control study is to learn if continuous glucose monitoring (CGM) can aid in weight loss in overweight/obese women with no other chronic condition. The primary hypothesis is that insights from CGM aid in greater weight loss, and the secondary hypothesis is that the use of CGM reduces the dropout rate from a three-month exercise program. Research will compare the results of weight loss after inclusion into 3 month physical exercise and diet counselling program between experimental group (women assigned to wear CGM) and control group (women without CGM). All participants will be included in the same physical exercise program with a fitness coach (3 times weekly for 60 minutes per sessions, three different resistance trainings), and will be given a calorie-controlled diet based on a weekly menu.

Conditions

Obesity and Overweight; the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• change from baseline in the body mass index and body composition

  we will measure, compare and report changes in body weight, BMI and body composition in women living with overweight/obesity allocated to lifestyle measures+CGM and lifestyle measures without CGM

  the study will last for 3 months

Secondary Outcomes (1)

• changes in drop out rate between women living with overweight/obesity allocated to lifestyle intervention+CGM and those on lifestyle intervention

  the study will last for 3 months

Study Arms (1)

experimental-randomized to isCGM

OTHER

experimental arm- participants randomized to isCGM during the 3 months lifestyle intervention trial duration control arm-participants not randomized to isCGM during the 3 months lifestyle intervention trial duration

Behavioral: resistance exercise and calorie restrictive diet

Interventions

resistance exercise and calorie restrictive diet BEHAVIORAL

experimental group will be randomized to isCGM during the lifestyle intervention trial while control group will participate in the same lifestyle intervention but will not use isCGM

experimental-randomized to isCGM

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Fitness centre "Fit by Ines"

Čakovec, 40000, Croatia

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD, specialist in internal medicine, subspecialist in endocrinology and diabetes

Model Details: women living with overweight/obesity will be allocated to either a group with or without addition of continuous glucose monitoring (CGM) in addition to lifestyle intervention

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: November 1, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

CR (1)