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Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

Primary Purpose

Childhood Obesity, Overweight and Obesity, Adolescent Obesity

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Diet high on protein (25E%/day)
Increased follow-up contact after attending a weight loss camp
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Eating Behavior, Eating Habit, Quality of Life, Dietary Habits, Eating Disorders

Eligibility Criteria

7 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Weight Loss Camp Hobro
  • Weight Loss Camp Fjordmark

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group (CG)

Follow-up group (FUG)

Intervention group (IG)

Arm Description

Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and regular follow-up.

Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and increased follow-up.

A higher protein diet (25E%/day) for the 10 weeks they attend the camp and increased follow-up.

Outcomes

Primary Outcome Measures

Change in Weight
Weight will be measured in kilograms using a Bioelectric impedance
Change in Height
Height will be measured in centimeter using a fixed wall measuring tape
Change in Body Mass Index (BMI)
Weight in kilograms and height in centimeter will be combined to report BMI in kg/m^2
Change in fat mass/fat free mass
Fat mass/fat free mass will be measured using a Bioelectric impedance.

Secondary Outcome Measures

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.
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").
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).
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.
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.
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.
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.

Full Information

First Posted
August 13, 2020
Last Updated
January 12, 2023
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04522921
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Overweight and Obesity, Adolescent Obesity, Adolescent Overweight, Diabetes
Keywords
Eating Behavior, Eating Habit, Quality of Life, Dietary Habits, Eating Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
ParticipantInvestigator
Masking Description
At enrollment the participants have no knowledge of which group they are assigned. The investigator has no knowledge of or influence on how participants are divided into different groups. Participants are assigned groups by the camp staff.
Allocation
Non-Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and regular follow-up.
Arm Title
Follow-up group (FUG)
Arm Type
Experimental
Arm Description
Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and increased follow-up.
Arm Title
Intervention group (IG)
Arm Type
Experimental
Arm Description
A higher protein diet (25E%/day) for the 10 weeks they attend the camp and increased follow-up.
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet high on protein (25E%/day)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Increased follow-up contact after attending a weight loss camp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight
Description
Weight will be measured in kilograms using a Bioelectric impedance
Time Frame
Changes from baseline to 10 weeks and 52-weeks follow-up.
Title
Change in Height
Description
Height will be measured in centimeter using a fixed wall measuring tape
Time Frame
Changes from baseline to 10 weeks and 52-weeks follow-up.
Title
Change in Body Mass Index (BMI)
Description
Weight in kilograms and height in centimeter will be combined to report BMI in kg/m^2
Time Frame
Changes from baseline to 10 weeks and 52-weeks follow-up.
Title
Change in fat mass/fat free mass
Description
Fat mass/fat free mass will be measured using a Bioelectric impedance.
Time Frame
Changes from baseline to 10 weeks and 52-weeks follow-up.
Secondary Outcome Measure Information:
Title
Change in children´s well-being
Description
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.
Time Frame
Changes from baseline to 10-weeks and 52-weeks follow-up
Title
Change in Eating Habits
Description
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").
Time Frame
Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up.
Title
Change in Eating Behaviour
Description
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).
Time Frame
Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up.
Title
Loss of Control Eating (LOC) episodes
Description
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.
Time Frame
Will be measured three consecutive months before the intervention and three consecutive months after the intervention.
Title
Metabolic markers
Description
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.
Time Frame
Changes from baseline to 10 weeks and 52-weeks follow-up.
Title
Liver markers
Description
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.
Time Frame
Changes from baseline to 10 weeks and 52-weeks follow-up.
Title
Inflammatory markers
Description
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.
Time Frame
Changes from baseline to 10 weeks and 52-weeks follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens M Bruun, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Loss Camp Hobro
City
Hobro
ZIP/Postal Code
9500
Country
Denmark
Facility Name
Weight Loss Camp Fjordmark
City
Kruså
ZIP/Postal Code
6340
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

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