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

NCT06126679 | Unknown

• 1 other identifier: LASLI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (2)

• To investigate the efficacy of the intervention for the ISO-BMI

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

  12 months

• The costs of the intervention for the health care system

  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).

  12 months

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Procedure: 1-year dietary and physical activity intervention of childhood obesity

control group

NO INTERVENTION

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

Interventions

1-year dietary and physical activity intervention of childhood obesity 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.

intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Clinical diagnosis of endocrine or mental diseases.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

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

Hyvinkää, Uusimaa, 05850, Finland

Location

Related Publications (1)

• 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.

  PMID: 39068465 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anni Martikainen

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical nutritionist

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 13, 2023
• Study Start: January 2, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)