Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04522921
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2020-08-13
Brief Title:
Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15Eday diet whereas the intervention group will consume a higher protein 25Eday 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None