Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (NCT04522921) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns
Denmark211 participantsStarted 2020-10-01
Plain-language summary
The main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. In a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet. Secondary, the investigators want to investigate the effect of frequent follow-up after the intervention, and the overall effect of the lifestyle camp.
Compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in BMI-SDS) or weight maintenance in children with overweight or obesity, and improve quality of life, and risk factors for type 2 diabetes.
Who can participate
Age range
7 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The child attends a multi-component-overnight camp in Hobro or Fjordmark between October 2020 and March 2022.
* The child is between 7 and 14 years of age (inclusive) while attending camp.
* At least one parent/guardian submit written and oral consent to participate with his/her child.
* Parent/legal guardian has submitted oral and written consent to participation of their child. In case of shared custody both parents must submit written and oral consent before their child can participate in the trial.
Exclusion Criteria:
* The child has a disease, diagnose or eating disorder that require treatment.
* The child or parent/guardian participate in another clinical trial or plan to do so in the near future.
* The parent/guardian do not understand the written informed consent.
* The child or parent/guardian are unwilling to or unable to comply with the study protocol and instruction given by the study staff.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body Mass Index Standard Deviation Score (BMI-SDS)
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)
2
Body Weight (kg)
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)
3
Body Fat (%)
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)
4
Skeletal Muscle Mass (kg)
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)