Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

• ClinicalTrials.gov Identifier: NCT04522921
• Recruitment Status: Active, not recruiting
• First Posted: August 21, 2020
• Last Update Posted: January 13, 2023
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

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.

Condition or disease	Intervention/treatment	Phase
Childhood Obesity; Overweight and Obesity; Adolescent Obesity; Adolescent Overweight; Diabetes	Dietary Supplement: Diet high on protein (25E%/day); Other: Increased follow-up contact after attending a weight loss camp	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 229 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment

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).

• Masking: Double (Participant, Investigator)

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.

• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: December 31, 2032

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Group (CG); Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and regular follow-up.
Experimental: Follow-up group (FUG); 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; 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.
Experimental: Intervention group (IG); 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); 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.; Other: Increased follow-up contact after attending a weight loss camp; 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change in children´s well-being [ Time Frame: Changes from baseline to 10-weeks and 52-weeks follow-up ]
   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.
2. Change in Eating Habits [ Time Frame: Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up. ]
   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").
3. Change in Eating Behaviour [ Time Frame: Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up. ]
   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).
4. Loss of Control Eating (LOC) episodes [ Time Frame: Will be measured three consecutive months before the intervention and three consecutive months after the intervention. ]
   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.
5. Metabolic markers [ Time Frame: Changes from baseline to 10 weeks and 52-weeks follow-up. ]
   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.
6. Liver markers [ Time Frame: Changes from baseline to 10 weeks and 52-weeks follow-up. ]
   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.
7. Inflammatory markers [ Time Frame: Changes from baseline to 10 weeks and 52-weeks follow-up. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Denmark

Weight Loss Camp Hobro

Hobro, Denmark, 9500

Weight Loss Camp Fjordmark

Kruså, Denmark, 6340

Sponsors and Collaborators

University of Aarhus

Investigators

• Principal Investigator: Jens M Bruun, Professor; Aarhus University Hospital

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04522921
• Other Study ID Numbers: The COPE-study
• First Posted: August 21, 2020
• Last Update Posted: January 13, 2023
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by University of Aarhus:

Eating Behavior; Eating Habit; Quality of Life; Dietary Habits; Eating Disorders

Additional relevant MeSH terms:

Diabetes Mellitus; Obesity; Pediatric Obesity; Overweight; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight