Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (COPE)

University of Aarhus

Status: Active, not recruiting

Conditions: Diabetes; Adolescent Overweight; Overweight and Obesity; Childhood Obesity; Adolescent Obesity

Treatments: Dietary Supplement: Diet with a higher amount of protein (25E% per day); Behavioral: Increased follow-up contact after the 10-week intervention; Dietary Supplement: Diet with a lower amount of protein (15E% per day)

Study type: Interventional

Funder types: Other

Identifiers

NCT04522921

The COPE-study

Details and patient eligibility

About

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. Secondary, the investigators want to investigate the effect of frequent follow-up after the intervention, and the overall effect of the lifestyle camp.

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 quality of life, and risk factors for type 2 diabetes.

Full 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 metabolic health and questionnaires investigating quality of life, eating behavior traits, eating habits and eating-related problems i.e., overeating and loss of control eating.

The children will be measured at baseline, 10-weeks and at a 52-weeks follow-up visit.

Furthermore, participants will be invited to follow-up visits 3 years, 5 years, 7 years and 10 years, respectively.

Enrollment: 211 patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The child attends a multi-component-overnight camp in Hobro or Fjordmark between October 2020 and March 2022.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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211 participants in 3 patient groups

SARS CoV-group

Other group

Description:

This group should have been the control group. However, due to the COVID19 lockdown of the camps for 5 five weeks, with no control of diet and physical activity, this group could not act as control group. Therefore, this group has been excluded from longitudinal analyses.

Treatment:

Dietary Supplement: Diet with a lower amount of protein (15E% per day)

Control Group (CG)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Diet with a lower amount of protein (15E% per day)

Behavioral: Increased follow-up contact after the 10-week intervention

Intervention group (IG)

Experimental group

Description:

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

Treatment:

Behavioral: Increased follow-up contact after the 10-week intervention

Dietary Supplement: Diet with a higher amount of protein (25E% per day)