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Hyvinkää Childhood Obesity Study (HCOS), Randomized Controlled Clinical Trial for Effectiveness and Costs of a 1-year Lifestyle Intervention.

Not Applicable
Active, not recruiting
Conditions
Childhood Obesity
Registration Number
NCT06126679
Lead Sponsor
Helsinki University Central Hospital
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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria

weight for height at least + 40 % or ≥ 30 % and it is rising

Exclusion Criteria

Clinical diagnosis of endocrine or mental diseases.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
To investigate the efficacy of the intervention for the ISO-BMI12 months

How much ISO-BMI change during the intervention (kg/m2)

The costs of the intervention for the health care system12 months

Investigators calculate the costs (euros) of the intervention (the price of research visits, laboratory tests, the salary of emplyees and the cost of research rooms).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Helsinki University Hospital, Non-operative Services, Internal Medicine and Rehabilitation, Clinical Nutrition Hyvinkää Hospital

🇫🇮

Hyvinkää, Uusimaa, Finland

Helsinki University Hospital, Non-operative Services, Internal Medicine and Rehabilitation, Clinical Nutrition Hyvinkää Hospital
🇫🇮Hyvinkää, Uusimaa, Finland

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