Clinical trial NCT04522921: Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns
Official title: Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (The COPE-study) - An Intervention Trial Investigating the Efficacy of Dietary Changes in Protein
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Childhood Obesity
Overweight and Obesity
Adolescent Obesity
Adolescent Overweight
Diabetes
Keywords: Eating Behavior
Eating Habit
Quality of Life
Dietary Habits
Eating Disorders
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 229
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 1. Control group (CG): Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and regular follow-up.
2. Follow-up group (FUG): Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and increased follow-up (once every month within the first 6 month and once every other month until 52-weeks follow-up).
3. Intervention group (IG): A higher protein diet (25E%/day) for the 10 weeks they attend the camp and increased follow-up (once every month within the first 6 month and once every other month until 52-weeks follow-up).
Primary purpose: PREVENTION

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. Furthermore, the investigators want to investigate the effect of frequent follow-up after intervention.

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 risk factors for type 2 diabetes and Quality of Life.

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 blood-tests measuring metabolic, inflammatory and liver markers and questionnaires investigating Quality of Life, Eating Behavior, Eating Habits and Disturbed Eating.

The children will be measured at baseline, 10-weeks and 52-weeks follow-up. Furthermore, participants will be invited to follow-up investigation 3 years, 5 years, 7 years and 10 years, respectively, after the intervention.

Eligibility criteria: Inclusion Criteria:

* The child attends a multi-component-overnight camp in Hobro or Fjordmark between September 2020 and December 2021.
* 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.

Primary outcomes:
measure: Change in Weight
timeFrame: Changes from baseline to 10 weeks and 52-weeks follow-up.
measure: Change in Height
timeFrame: Changes from baseline to 10 weeks and 52-weeks follow-up.
measure: Change in Body Mass Index (BMI)
timeFrame: Changes from baseline to 10 weeks and 52-weeks follow-up.
measure: Change in fat mass/fat free mass
timeFrame: Changes from baseline to 10 weeks and 52-weeks follow-up.
Secondary outcomes:
measure: Change in children´s well-being
timeFrame: Changes from baseline to 10-weeks and 52-weeks follow-up
measure: Change in Eating Habits
timeFrame: Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up.
measure: Change in Eating Behaviour
timeFrame: Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up.
measure: Loss of Control Eating (LOC) episodes
timeFrame: Will be measured three consecutive months before the intervention and three consecutive months after the intervention.
measure: Metabolic markers
timeFrame: Changes from baseline to 10 weeks and 52-weeks follow-up.
measure: Liver markers
timeFrame: Changes from baseline to 10 weeks and 52-weeks follow-up.
measure: Inflammatory markers
timeFrame: Changes from baseline to 10 weeks and 52-weeks follow-up.
Other outcomes:
Locations:
city: Hobro
country: Denmark
facility: Weight Loss Camp Hobro
city: Kruså
country: Denmark
facility: Weight Loss Camp Fjordmark
Study officials:
affiliation: Aarhus University Hospital
name: Jens M Bruun, Professor
role: PRINCIPAL_INVESTIGATOR
References: