Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

N/AActive Not RecruitingNCT04522921

University of Aarhus211 enrolled

Overview

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.

The study will be performed in collaboration with the staff of the well-established multi-component-overnight camps (Julemærkehjem) in Denmark. The multi-component-overnight camps are intensive weight loss camps to which Danish schoolchildren, from 7-14 years of age, are referred to for 10-weeks intervention focusing on healthy lifestyle, healthy eating, new habits and increased physical activity. The primary outcome is anthropometry (BMI-SDS, fat mass, fat-free mass). Secondary outcomes are metabolic health and questionnaires investigating quality of life, eating behavior traits, eating habits and eating-related problems i.e., overeating and loss of control eating. The children will be measured at baseline, 10-weeks and at a 52-weeks follow-up visit. Furthermore, participants will be invited to follow-up visits 3 years, 5 years, 7 years and 10 years, respectively.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

211

Interventions

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 interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Weight Loss Camp Hobro

Hobro, Denmark

Weight Loss Camp Fjordmark

Kruså, Denmark