Clinical trial

Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04522921

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age7 Years to 14 Years

SexAll

Healthy volunteersAccepted

ConditionChildhood Obesity, Overweight and Obesity, Adolescent Obesity, Adolescent Overweight, Diabetes

Full registry criteria

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.

Treatments and study arms

Diet with a higher amount of protein (25E% per day)

Dietary Supplement

In a caloric restricted and increased physical activity setting, the participants will be served a higher protein (25E%/day) diet.

Increased follow-up contact after the 10-week intervention

Behavioral

Both the control-group and the intervention-group were offered an increased follow-up contact after camp.

Diet with a lower amount of protein (15E% per day)

Dietary Supplement

In a caloric restricted and increased physical activity setting, the participants will be served a low-moderate protein (15E%/day) diet.

Primary outcomes

Body Mass Index Standard Deviation Score (BMI-SDS)Mean changes from baseline to 10-weeks (post camp intervention)

BMI-SDS was calculated using World Health Organization Anthro-Plus software.

Body Weight (kg)Mean changes from baseline to 10-weeks (post camp intervention)

Body weight (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

Body Fat (%)Mean changes from baseline to 10-weeks (post camp intervention)

Body fat (%) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

Skeletal Muscle Mass (kg)Mean changes from baseline to 10-weeks (post camp intervention)

Skeletal muscle mass (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Weight Loss Camp Hobro🇩🇰 Hobro, Denmark

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Weight Loss Camp Fjordmark🇩🇰 Kruså, Denmark

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