Obesity and OverweightNCT07026903
The Impact of CGM on Weight Reduction
A study testing resistance exercise and calorie restrictive diet in people with Obesity and Overweight and the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring, run by University of Zagreb at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity and Overweight, the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring
- What is being tested?
- resistance exercise and calorie restrictive diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2024to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: females, age over 18 years, overweight/obese
Exclusion Criteria: prediabetes/diabetes, significant anemia, clinically manifest hypo- or hyperthyroidism, recent musculoskeletal injuries that would limit participation in the exercise
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of CGM on Weight Reduction in Women With Overweight/Obesity Without Accompanying Chronic Diseases
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.
Read the detailed description
In this prospective study lasting 3 months, a total of 40 participants are planned to be included. The sample size was calculated using the free G Power program. For differences within the group (before-after measurements, 2 measurements), the required number of participants in one group would be 16 (with a power of 0.8 and the calculated effect size based on previous research = 0.66). Considering that differences between two groups will also be observed, the calculation was made more conservatively, using a moderate effect size factor for ANOVA for repeated measures (within-between interaction), and with a minimum required power of 0.8 and an effect size of 0.25, the total number of required participants is 28, which means 14 per group, assuming three BMI measurements. Due to the potential dropout rate, the sample size was increased to 20 participants per group. Participants will be recruited upon enrollment at the fitness center. Participants will be randomly divided into two groups; one that will use isCGM (FreeStyle Libre 2) for glucose control and nutritional choices, and a group without CGM (the control group). At the beginning of the study, all participants will have their body composition measured on a scale, BMI, waist and hip circumference, triceps skinfold thickness, and blood samples taken for biochemical analyses (CBC, glucose, HbA1c, lipid profile, aminotransferases, fT4, and TSH). Blood tests will be analyzed in the private laboratory. Only those participants who do not have glucose metabolism disorders (prediabetes or diabetes), significant anemia, clinically manifest hypo- or hyperthyroidism, or recent musculoskeletal injuries that would limit their participation in the exercise program will be included in the further study. All participants will undergo nutritional counseling and receive a proposal for a calorie-controlled diet based on a weekly menu. Participants will be asked to keep a food diary. Additionally, all participants will follow the same exercise program for 3 months under the professional guidance of a kinesiologist. Exercise will be conducted 3 times a week for 60 minutes in groups of up to 5 participants, and will include three different training sessions with external and bodyweight resistance. In the case of external resistance, weights will be adjusted according to the participants' status so that they can complete the assigned number of repetitions, and in the case of bodyweight exercises, participants who cannot complete the prescribed series will be allowed to take breaks between repetitions. At the midpoint of the program, after 1.5 months of research, body composition will be re-evaluated on the scale, and measurements of the triceps skinfold and waist and hip circumference will be repeated. Participants assigned to the CGM group will wear sensors (FreeStyle Libre 2, Abbott) for 2 weeks three times during the study (at the beginning, after 1.5 months, and after 3 months). At the end of the program, anthropometric measurements and biochemical indicators will be repeated as at the beginning of the study. Data will only be analyzed for those participants who attend more than 90% of the exercise sessions. Dropout rates and participant satisfaction with the program will be monitored, knowledge of macronutrients will be compared before and after the program, and initial and control laboratory results and anthropometric measures will be compared.
- Conditions
- Obesity and Overweight, the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring
- Being tested
- resistance exercise and calorie restrictive diet
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance exercise and calorie restrictive dietBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: resistance exercise and calorie restrictive diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
we hypothesize that addition of CGM to lifestyle intervention will improve the adherence rate
Measured: the study will last for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Nov 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Cigrovski Berkovic, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026903
- Sponsor's protocol ID
- 84
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of CGM on Weight Reduction in Women With Overweight/Obesity Without Accompanying Chronic Diseases
- ClinicalTrials.gov ID
- NCT07026903
- Acronym / sponsor ID
- 84
- Conditions
- Obesity and Overweight, the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this prospective study lasting 3 months, a total of 40 participants are planned to be included. The sample size was calculated using the free G Power program. For differences within the group (before-after measurements, 2 measurements), the required number of participants in one group would be 16 (with a power of 0.8 and the calculated effect size based on previous research = 0.66). Considering that differences between two groups will also be observed, the calculation was made more conservatively, using a moderate effect size factor for ANOVA for repeated measures (within-between interaction), and with a minimum required power of 0.8 and an effect size of 0.25, the total number of required participants is 28, which means 14 per group, assuming three BMI measurements. Due to the potential dropout rate, the sample size was increased to 20 participants per group. Participants will be recruited upon enrollment at the fitness center. Participants will be randomly divided into two groups; one that will use isCGM (FreeStyle Libre 2) for glucose control and nutritional choices, and a group without CGM (the control group). At the beginning of the study, all participants will have their body composition measured on a scale, BMI, waist and hip circumference, triceps skinfold thickness, and blood samples taken for biochemical analyses (CBC, glucose, HbA1c, lipid profile, aminotransferases, fT4, and TSH). Blood tests will be analyzed in the private laboratory. Only those participants who do not have glucose metabolism disorders (prediabetes or diabetes), significant anemia, clinically manifest hypo- or hyperthyroidism, or recent musculoskeletal injuries that would limit their participation in the exercise program will be included in the further study. All participants will undergo nutritional counseling and receive a proposal for a calorie-controlled diet based on a weekly menu. Participants will be asked to keep a food diary. Additionally, all participants will follow the same exercise program for 3 months under the professional guidance of a kinesiologist. Exercise will be conducted 3 times a week for 60 minutes in groups of up to 5 participants, and will include three different training sessions with external and bodyweight resistance. In the case of external resistance, weights will be adjusted according to the participants' status so that they can complete the assigned number of repetitions, and in the case of bodyweight exercises, participants who cannot complete the prescribed series will be allowed to take breaks between repetitions. At the midpoint of the program, after 1.5 months of research, body composition will be re-evaluated on the scale, and measurements of the triceps skinfold and waist and hip circumference will be repeated. Participants assigned to the CGM group will wear sensors (FreeStyle Libre 2, Abbott) for 2 weeks three times during the study (at the beginning, after 1.5 months, and after 3 months). At the end of the program, anthropometric measurements and biochemical indicators will be repeated as at the beginning of the study. Data will only be analyzed for those participants who attend more than 90% of the exercise sessions. Dropout rates and participant satisfaction with the program will be monitored, knowledge of macronutrients will be compared before and after the program, and initial and control laboratory results and anthropometric measures will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| experimental-randomized to isCGM | Other | Behavioral: resistance exercise and calorie restrictive dietexperimental 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resistance exercise and calorie restrictive dietexperimental 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 | Behavioural | experimental-randomized to isCGM |
Primary outcome
change from baseline in the body mass index and body composition
Time frame: the study will last for 3 months
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
1 secondary outcome
changes in drop out rate between women living with overweight/obesity allocated to lifestyle intervention+CGM and those on lifestyle intervention
Time frame: the study will last for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance exercise and calorie restrictive diet in people with Obesity and Overweight and the Study Will Focus on Weight Reduction Through Lifestyle Changes Aided by Insights From Continuous Glucose Monitoring, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in the body mass index and body composition (time frame: the study will last for 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.