Clinical trial NCT06126679: Hyvinkää Childhood Obesity Study (HCOS), Randomized Controlled Clinical Trial for Effectiveness and Costs of a 1-year Lifestyle Intervention.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 80 children are recruited for this study and they randomize 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Clinical diagnosis of endocrine or mental diseases.

Primary outcomes:
measure: To investigate the efficacy of the intervention for the ISO-BMI
timeFrame: 12 months
measure: The costs of the intervention for the health care system
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyvinkää
country: Finland
facility: Helsinki University Hospital, Non-operative Services, Internal Medicine and Rehabilitation, Clinical Nutrition Hyvinkää Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Anni Martikainen
role: PRINCIPAL_INVESTIGATOR
References: