Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04522921
• Other study ID #: The COPE-study
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2032

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 229
• Est. completion date: December 31, 2032
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Obesity
• Adolescent Overweight
• Childhood Obesity
• Diabetes
• Diabetes Mellitus
• Obesity
• Overweight
• Overweight and Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Denmark	Weight Loss Camp Hobro	Hobro
Denmark	Weight Loss Camp Fjordmark	Kruså

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Weight will be measured in kilograms using a Bioelectric impedance	Changes from baseline to 10 weeks and 52-weeks follow-up.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.