Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

Study Results

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2032-12-31

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. 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.

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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 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.

Conditions

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Childhood Obesity Overweight and Obesity Adolescent Obesity Adolescent Overweight Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

1. SARS CoV group (former control group): Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp, however, due to a COVID19 lockdown of the camps, these children were sent home for five weeks, and therefore excluded from longitudinal comparison between the groups.
2. Control group (CG): Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp.

2\) Intervention group (IG): A higher protein diet (25E%/day) for the 10 weeks they attend the camp.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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SARS CoV-group

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.

Group Type OTHER

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

Intervention Type DIETARY_SUPPLEMENT

In a caloric restricted and increased physical activity setting, the participants will be served a low-moderate protein (15E%/day) diet.

Control Group (CG)

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

Group Type ACTIVE_COMPARATOR

Increased follow-up contact after the 10-week intervention

Intervention Type BEHAVIORAL

Both the control-group and the intervention-group were offered an increased follow-up contact after camp.

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

Intervention Type DIETARY_SUPPLEMENT

In a caloric restricted and increased physical activity setting, the participants will be served a low-moderate protein (15E%/day) diet.

Intervention group (IG)

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

In a caloric restricted and increased physical activity setting, the participants will be served a higher protein (25E%/day) diet.

Increased follow-up contact after the 10-week intervention

Intervention Type BEHAVIORAL

Both the control-group and the intervention-group were offered an increased follow-up contact after camp.

Interventions

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

In a caloric restricted and increased physical activity setting, the participants will be served a higher protein (25E%/day) diet.

Intervention Type DIETARY_SUPPLEMENT

Increased follow-up contact after the 10-week intervention

Both the control-group and the intervention-group were offered an increased follow-up contact after camp.

Intervention Type BEHAVIORAL

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

In a caloric restricted and increased physical activity setting, the participants will be served a low-moderate protein (15E%/day) diet.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes