Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

Not Applicable

Active, not recruiting

Conditions: Overweight and Obesity
Childhood Obesity
Diabetes
Adolescent Obesity
Adolescent Overweight

Registration Number: NCT04522921

Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 211

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Body Height (m)	Mean changes from baseline to 10-weeks (post camp intervention)	Height (m) was measured using a fixed wall measuring tape.
Systolic Blood Pressure	Mean changes from baseline to 10-weeks (post camp intervention)	Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).
Diastolic Blood Pressure	Mean changes from baseline to 10-weeks (post camp intervention)	Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).
P-cholesterol	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
ALAT	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
ASAT	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
HDL Cholesterol	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
LDL Cholesterol	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
P-glucose	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
P-tryglyceride	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
GGT	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Basic Phosphatase	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
HbA1c	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Albumin	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
CD163	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Platelets	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Uric Acid	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.