Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

NCT04522921 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2026-04-29

Study results available
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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.

Conditions

  • Childhood Obesity
  • Overweight and Obesity
  • Adolescent Obesity
  • Adolescent Overweight
  • Diabetes

Interventions

DIETARY_SUPPLEMENT

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

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

BEHAVIORAL

Increased follow-up contact after the 10-week intervention

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

DIETARY_SUPPLEMENT

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

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jens M Bruun, Professor · Aarhus University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-06-30
Completion
2032-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04522921 on ClinicalTrials.gov