Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126679
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-10-09
Brief Title:
Hyvinkää Childhood Obesity Study HCOS Randomized Controlled Clinical Trial for Effectiveness and Costs of a 1-year Lifestyle Intervention
Sponsor:
Helsinki University Central Hospital
Organization:
Helsinki University Central Hospital
Study Overview
Official Title:
Effectiveness and Cost Effectiveness of a 1-year Dietary and Physical Activity Intervention of Childhood Obesity - Study Protocol for a Randomized Controlled Clinical Trial
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:
HCOS
Brief Summary:
The aim of this study is to evaluate the effects of lifestyle intervention on the management of childhood overweight and to explore the factors that contribute to the outcome as well as the costs for the health care system The hypotheses of the study are that lifestyle intervention is efficient in reducing BMI-SDS and thus effective in preventing overweight to progress to obesity and it is also cost effective
The research is necessary for the development of overweight treatment and try to find out the optimal duration and intensity for the treatment and content useful for clinical work
The research is necessary for the development of overweight treatment and try to find out the optimal duration and intensity for the treatment and content useful for clinical work
Detailed Description:
Methods and analyses The aim of this study is to recruit 80 children and to randomize them either to an intervention group or a control group with standard care Intervention group receive intensive family-based diet and physical activity counseling deliver by a multidisciplinary team of a pediatrician a nurse and a clinical nutritionist Control group do not receive any lifestyle intervention during the study The inclusion criteria are weight-for-height 40 or 30 and increasing and age of 6-12 years All participants fill out the study questionnaires and plasma samples are taken at baseline and at 12 months Outcome variables will be compared between intervention and control groups
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