Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (The COPE-study) - An Non-randomized Intervention Trial Investigating the Efficacy of Dietary Changes in Protein

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04522921

Acronym

COPE

Enrollment

211

Registered

2020-08-21

Start date

2020-10-01

Completion date

2032-12-31

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Obesity, Adolescent Overweight, Childhood Obesity, Diabetes, Overweight and Obesity

Keywords

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

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. 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.

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 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.

Interventions

DIETARY_SUPPLEMENTDiet 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.

BEHAVIORALIncreased 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.

DIETARY_SUPPLEMENTDiet 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, 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.

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

7 Years to 14 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Body Mass Index Standard Deviation Score (BMI-SDS)	Mean changes from baseline to 10-weeks (post camp intervention)	BMI-SDS was calculated using World Health Organization Anthro-Plus software.
Body Weight (kg)	Mean changes from baseline to 10-weeks (post camp intervention)	Body weight (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Body Fat (%)	Mean changes from baseline to 10-weeks (post camp intervention)	Body fat (%) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Skeletal Muscle Mass (kg)	Mean changes from baseline to 10-weeks (post camp intervention)	Skeletal muscle mass (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

Secondary

Measure	Time frame	Description
Body Height (m)	Mean changes from baseline to 10-weeks (post camp intervention)	Height (m) was measured using a fixed wall measuring tape.
Systolic Blood Pressure	Mean changes from baseline to 10-weeks (post camp intervention)	Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).
Diastolic Blood Pressure	Mean changes from baseline to 10-weeks (post camp intervention)	Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).
P-cholesterol	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
HDL Cholesterol	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
LDL Cholesterol	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
P-tryglyceride	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
ALAT	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
ASAT	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
GGT	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Basic Phosphatase	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
HbA1c	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
P-glucose	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Albumin	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
CD163	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Platelets	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Uric Acid	Mean changes from baseline to 10-weeks (post camp intervention)	Educated bio-analysts were responsible for collecting blood samples in a subsample of children.

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORJens M Bruun, Professor

Aarhus University Hospital

Participant flow

Participants by arm

Arm	Count
Control-group In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.	75
Intervention-group In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \ 10-15E% to \ 25E% per day with minimal changes in total caloric intake.	86
SARS CoV-group The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.	34
Total	195

Baseline characteristics

Characteristic	Control-group	Intervention-group	Total	SARS CoV-group
Age, Continuous	12.2 years STANDARD_DEVIATION 1.4	12.1 years STANDARD_DEVIATION 1.5	12.2 years STANDARD_DEVIATION 1.4	12.5 years STANDARD_DEVIATION 1.1
ALAT	22 units/L	22.5 units/L	22 units/L	20 units/L
Albumin	42.0 g/L STANDARD_DEVIATION 2.4	42.8 g/L STANDARD_DEVIATION 2.4	42.4 g/L STANDARD_DEVIATION 2.4	43 g/L STANDARD_DEVIATION 1.9
ASAT	24 units/L	23 units/L	23 units/L	16 units/L
Basic phosphatase	297 units/L STANDARD_DEVIATION 84	274 units/L STANDARD_DEVIATION 90	284 units/L STANDARD_DEVIATION 87	251 units/L STANDARD_DEVIATION 77
Blood pressure (diastolic)	70.2 mmHg STANDARD_DEVIATION 6.4	72.5 mmHg STANDARD_DEVIATION 8.7	71.3 mmHg STANDARD_DEVIATION 7.7	71.7 mmHg STANDARD_DEVIATION 5.1
Blood pressure (systolic)	111.1 mmHg STANDARD_DEVIATION 10.7	109.8 mmHg STANDARD_DEVIATION 10.31	110.5 mmHg STANDARD_DEVIATION 10.5	109.2 mmHg STANDARD_DEVIATION 9.1
Body fat	41.4 percentage of body fat STANDARD_DEVIATION 6.6	41.0 percentage of body fat STANDARD_DEVIATION 6.8	41.2 percentage of body fat STANDARD_DEVIATION 6.7	42.4 percentage of body fat STANDARD_DEVIATION 6
Body mass index standard deviation score (BMI-SDS)	2.65 standard deviation STANDARD_DEVIATION 0.7	2.66 standard deviation STANDARD_DEVIATION 0.7	2.65 standard deviation STANDARD_DEVIATION 0.7	2.57 standard deviation STANDARD_DEVIATION 0.6
Body weight	73.6 Kg STANDARD_DEVIATION 14.6	72.7 Kg STANDARD_DEVIATION 18	73.2 Kg STANDARD_DEVIATION 16.5	73.4 Kg STANDARD_DEVIATION 12.5
CD163	2.4 mg/L	2.6 mg/L	2.5 mg/L	2.1 mg/L
GGT	16 units/L	16 units/L	16 units/L	15 units/L
HbA1c	34.9 mmol/mol STANDARD_DEVIATION 2.5	35.0 mmol/mol STANDARD_DEVIATION 2.1	34.9 mmol/mol STANDARD_DEVIATION 2.3	35 mmol/mol STANDARD_DEVIATION 2.8
HDL cholesterol	1.2 mmol/L STANDARD_DEVIATION 0.3	1.2 mmol/L STANDARD_DEVIATION 0.2	1.2 mmol/L STANDARD_DEVIATION 0.2	1.2 mmol/L STANDARD_DEVIATION 0.3
Height	1.59 Meter STANDARD_DEVIATION 0.1	1.59 Meter STANDARD_DEVIATION 0.1	1.59 Meter STANDARD_DEVIATION 0.1	1.60 Meter STANDARD_DEVIATION 0.1
LDL cholesterol	2.2 mmol/L STANDARD_DEVIATION 0.6	2.5 mmol/L STANDARD_DEVIATION 0.6	2.4 mmol/L STANDARD_DEVIATION 0.6	2.2 mmol/L STANDARD_DEVIATION 0.6
P-glucose	5.9 mmol/L STANDARD_DEVIATION 0.4	5.9 mmol/L STANDARD_DEVIATION 0.3	5.9 mmol/L STANDARD_DEVIATION 0.3	5.9 mmol/L STANDARD_DEVIATION 0.4
Platelets	314 units/L STANDARD_DEVIATION 64	310 units/L STANDARD_DEVIATION 61	312 units/L STANDARD_DEVIATION 62	295 units/L STANDARD_DEVIATION 29
Race and Ethnicity Not Collected	—	—	0 Participants	—
Sex: Female, Male Female	36 Participants	35 Participants	90 Participants	19 Participants
Sex: Female, Male Male	39 Participants	51 Participants	105 Participants	15 Participants
Skeletal muscle mass	23.0 Kg STANDARD_DEVIATION 4.8	23.2 Kg STANDARD_DEVIATION 5.8	23.1 Kg STANDARD_DEVIATION 5.4	22.8 Kg STANDARD_DEVIATION 4.2
Total cholesterol	3.9 mmol/L STANDARD_DEVIATION 0.7	4.3 mmol/L STANDARD_DEVIATION 0.7	4.2 mmol/L STANDARD_DEVIATION 0.7	4.0 mmol/L STANDARD_DEVIATION 0.8
Triglyceride	1.3 mmol/L	1.3 mmol/L	1.3 mmol/L	1.3 mmol/L
Uric acid	0.31 mmol/L STANDARD_DEVIATION 0	0.32 mmol/L STANDARD_DEVIATION 0.1	0.31 mmol/L STANDARD_DEVIATION 0.1	0.33 mmol/L STANDARD_DEVIATION 0.1

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 195
other Total, other adverse events	0 / 195
serious Total, serious adverse events	0 / 195

Outcome results

Primary

Body Fat (%)

Body fat (%) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).