Childhood ObesityHCOSNCT06126679
Hyvinkää Childhood Obesity Study (HCOS), Randomized Controlled Clinical Trial for Effectiveness and Costs of a 1-year Lifestyle Intervention.
A study testing 1-year dietary and physical activity intervention of childhood obesity in people with Childhood Obesity, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- 1-year dietary and physical activity intervention of childhood obesity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 2 Jan 2019to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- weight for height at least + 40 % or ≥ 30 % and it is rising
Who cannot join
- Clinical diagnosis of endocrine or mental diseases.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Hospital, Non-operative Services, Internal Medicine and Rehabilitation, Clinical Nutrition Hyvinkää Hospital
Hyvinkää, Uusimaa, 05850
About this study
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
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.
Read the 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
- Being tested
- 1-year dietary and physical activity intervention of childhood obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-year dietary and physical activity intervention of childhood obesityProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the efficacy of the intervention for the ISO-BMI
How much ISO-BMI change during the intervention (kg/m2)
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start2 Jan 2019
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anni Martikainen, Helsinki University Central Hospital
- Investigators
- Anni Martikainen, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126679
- Sponsor's protocol ID
- LASLI
- Acronym
- HCOS
- Status last verified
- Nov 2023
- First submitted
- 9 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martikainen A, Eloranta AM, Schwab U, Ormala T. The 1-year obesity treatment intervention can improve fasting plasma glucose in children aged 6-12 years: randomized controlled trial. Trials. 2026 May 18;27(1):482. doi: 10.1186/s13063-026-09768-3.
PubMed 42152130Martikainen 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.
PubMed 39068465
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06126679
- Acronym / sponsor ID
- HCOS / LASLI
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: 1-year dietary and physical activity intervention of childhood obesityThe 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. |
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- weight for height at least + 40 % or ≥ 30 % and it is rising
Key exclusion criteria (1 listed)
- Clinical diagnosis of endocrine or mental diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-year dietary and physical activity intervention of childhood obesityThe 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. | Procedure or surgery | intervention group |
Primary outcome
To investigate the efficacy of the intervention for the ISO-BMI
Time frame: 12 months
How much ISO-BMI change during the intervention (kg/m2)
The costs of the intervention for the health care system
Time frame: 12 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 42152130Martikainen A, Eloranta AM, Schwab U, Ormala T. The 1-year obesity treatment intervention can improve fasting plasma glucose in children aged 6-12 years: randomized controlled trial. Trials. 2026 May 18;27(1):482. doi: 10.1186/s13063-026-09768-3.
- Derived from this study: PubMed 39068465Martikainen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anni Martikainen principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-year dietary and physical activity intervention of childhood obesity in people with Childhood Obesity, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the efficacy of the intervention for the ISO-BMI (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06126679, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.