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

NCT ID: NCT06126679

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2024-12-01

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. The multidisciplinary team consists of one pediatrician, one specialist nurse and a clinical nutritionist. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time.

The treatment is based on educational and behavioural counselling and motivating the participants to change their lifestyle and to support the parents in managing their children´s behaviour. The aim of counselling is to increase awareness of healthy dietary and physical activity habits; to achieve a suitable energy balance, to create a positive attitude to physical activity, to promote optimal sleep duration and to improve the children´s body image and body control.

Group Type: EXPERIMENTAL

1-year dietary and physical activity intervention of childhood obesity

Intervention Type: PROCEDURE

The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time.

The participants in the intervention group are advised and motivated to increase their regular daily physical activity and to reduce sedentary habits. They have one group session for the training in the gymnasium with physical education instructor. The physical education instructor gives a voluntary lecture for parents about increasing physical activity and reducing sedentary time.

control group

Participants in the control group continue with the standard care in primary care and do not receive any special lifestyle intervention during the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

1-year dietary and physical activity intervention of childhood obesity

The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time.

The participants in the intervention group are advised and motivated to increase their regular daily physical activity and to reduce sedentary habits. They have one group session for the training in the gymnasium with physical education instructor. The physical education instructor gives a voluntary lecture for parents about increasing physical activity and reducing sedentary time.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anni Martikainen

clinical nutritionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anni Martikainen

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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

Hyvinkää, Uusimaa, Finland

Countries

Finland

References

Martikainen A, Eloranta AM, Schwab U, Ormala T. Effectiveness and cost-effectiveness of a 1-year dietary and physical activity intervention of childhood obesity-study protocol for a randomized controlled clinical trial. Trials. 2024 Jul 27;25(1):508. doi: 10.1186/s13063-024-08348-7.

Reference Type: DERIVED

PMID: 39068465 (View on PubMed)

Other Identifiers

LASLI

Identifier Type: -

Identifier Source: org_study_id