Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (The COPE-study) - An Intervention Trial Investigating the Efficacy of Dietary Changes in Protein

Conditions
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Childhood Obesity, Overweight and Obesity, Adolescent Obesity, Adolescent Overweight, Diabetes

Intervention / Treatment
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* Dietary Supplement: Diet high on protein (25E%/day)
* Other: Increased follow-up contact after attending a weight loss camp


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Control group (CG): Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and regular follow-up. 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). 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (CG)<br>Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and regular follow-up. | |
| Experimental: Follow-up group (FUG)<br>Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and increased follow-up. | Other: Increased follow-up contact after attending a weight loss camp<br>* After leaving the camp, the children and their families with increased follow-up contact will be contacted once every month within the first 6 month and once every other month until 52-weeks follow-up (8 times total). The children and their families will be contacted by phone, facetime or skype as they prefer, within a predetermined and known timeframe. The conversation will focus on individual topics chosen by the child/parent.<br>|
| Experimental: Intervention group (IG)<br>A higher protein diet (25E%/day) for the 10 weeks they attend the camp and increased follow-up. | Dietary Supplement: Diet high on protein (25E%/day)<br>* 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.<br>Other: Increased follow-up contact after attending a weight loss camp<br>* After leaving the camp, the children and their families with increased follow-up contact will be contacted once every month within the first 6 month and once every other month until 52-weeks follow-up (8 times total). The children and their families will be contacted by phone, facetime or skype as they prefer, within a predetermined and known timeframe. The conversation will focus on individual topics chosen by the child/parent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Weight will be measured in kilograms using a Bioelectric impedance | Changes from baseline to 10 weeks and 52-weeks follow-up. | 
| Change in Height | Height will be measured in centimeter using a fixed wall measuring tape | Changes from baseline to 10 weeks and 52-weeks follow-up. | 
| Change in Body Mass Index (BMI) | Weight in kilograms and height in centimeter will be combined to report BMI in kg/m^2 | Changes from baseline to 10 weeks and 52-weeks follow-up. | 
| Change in fat mass/fat free mass | Fat mass/fat free mass will be measured using a Bioelectric impedance. | Changes from baseline to 10 weeks and 52-weeks follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in children´s well-being | Children´s well-being will be measured using the Children PedsQL4.0 questionnaire. A 5-point ordinal scale is used to score how big a problem everyday events are (the minimum value will be never a problem and the maximum value will be almost always a problem). Items are reverse-scored and linearly transformed so that higher scores indicate higher well-being. | Changes from baseline to 10-weeks and 52-weeks follow-up | 
| Change in Eating Habits | Eating habits will be measured using the Children's Eating Habits Questionnaire-FFQ. The FFQ contains forty-three food groups clustered into thirty-six according to their nutritional profiles. On an 8-point ordinal scale children will answer how frequent they consumed different food groups (the minimum value will be never/less than once a week and the maximum value will be 4 or more times/week). | Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up. | 
| Change in Eating Behaviour | Eating Behaviour will be measured using the Child Eating Behaviour Questionnaire (CEBQ). CEBQ questions are grouped into 8 subgroups: food responsiveness (FR), enjoyment of food (EF), desire to drink (DD), satiety responsiveness (SR), slowness in eating (SE), food fussiness (FF), emotional overeating (EOE) and emotional undereating (EUE). Questions will be answered on a 5-point ordinal scale (the minimum value will be never and the maximum value will be always). Overweight and obese children will scores higher in 'food approach' subgroups (i.e. FR, DD, EF, EOE) and lower in 'food avoidant' subgroups (i.e. SR, SE, EUE, FF). | Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up. | 
| Loss of Control Eating (LOC) episodes | LOC eating will be measured using two questions from the Eating Disorder examination questionnaire (EDE-Q 6.0) and measured on a ratio-interval scale and 0 will be the minimum value. Recurrent LOC eating is defined by >4 LOC episodes within the past 28 days. LOC eating must be investigated over three consecutive months before evaluation. | Will be measured three consecutive months before the intervention and three consecutive months after the intervention. | 
| Metabolic markers | A blood test will collected to measure metabolic markers (HbA1c, urate, lipids (total, high-density lipoprotein (HDL)-, and low-density lipoprotein (LDL) cholesterol, and triglycerides), fasting plasma glucose). Units of measure will be the same in all. | Changes from baseline to 10 weeks and 52-weeks follow-up. | 
| Liver markers | A blood test will collected to measure liver markers (Asat, Alat, alkaline phosphatase, platlets, GGT, albumine). Units of measure will be the same in all. | Changes from baseline to 10 weeks and 52-weeks follow-up. | 
| Inflammatory markers | A blood test will collected to measure inflammatory markers (High-sensitive C-reactive protein (hs-CRP), Interleukin(IL)-6, IL-8, leptin, adiponectin, cluster of differentiation(CD)163, CD36, fibroblast growth factor(FGF)-21, monocyte chemoattractant protein(MCP)-1, and Growth/differentiation factor (GDF)15). Units of measure will be the same in all. | Changes from baseline to 10 weeks and 52-weeks follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating Behavior, Eating Habit, Quality of Life, Dietary Habits, Eating Disorders