Overweight010Fit'RNCT07419503
010Fit'R - Healthy Lifestyle Interventions for Children With Overweight
A study testing 010 Fit'R intervention in people with Overweight and Children, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Overweight is a leading risk factor for non-communicable diseases. In the Netherlands, about 11% of children aged 4-12 years are overweight. The causes of childhood overweight are multifaceted, involving (epi)genetic, environmental, socioeconomic, and behavioral factors. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Children
- What is being tested?
- 010 Fit'R intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child participates in the 010Fit'R program and is between 4 and 12 years old (at the start of recruitment)
- Parents of children participating in the 010 Fit'R program
- Provider (e.g. participate in interview) is actively involved in promoting, implementing or conducting a healthy lifestyle intervention funded by 010Fit'R
- All participants should be able to comprehend provided information to make an informed decision for participation and should provide consent for participating. In case of children the parent(s) consent, as well as the child when 12 years old.
Who cannot join
- Outside of the age range, no consent for participation from provider, parent and/or child
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Department of Public Health, Erasmus MC University Medical Center
Rotterdam, South Holland, 3015GD
About this study
Official title: 010 Fit'R 2025-2027: Approach for Children (4-12 Years Old) With Overweight
Overweight is a leading risk factor for non-communicable diseases. In the Netherlands, about 11% of children aged 4-12 years are overweight. The causes of childhood overweight are multifaceted, involving (epi)genetic, environmental, socioeconomic, and behavioral factors. The societal consequences are far-reaching, including lower academic performance, reduced quality of life and a greater risk of developing obesity in adulthood.
Lifestyle interventions with diet and physical activity components have been shown to effectively reduce childhood overweight. The "010 Fit'R - Rotterdam approach for children with overweight" targets children between 4 and 12 years old and their parents. The program consists of multicomponent interventions addressing various lifestyle aspects, such as physical activity, nutrition, motor skills and healthy behaviours aiming to foster sustainable lifestyle changes. Providers were invited by the municipality of Rotterdam to develop interventions within the policy framework of 010 Fit'R. 12 providers were selected by the municipality based on the selection criteria (quality of the program; experience with the activities and target group; demonstrable connection with the area; connection with the target group; recruitment strategy; costs) and distributed over different neighbourhoods. This study evaluates the healthy lifestyle interventions involved in 010 Fit'R in terms of effectiveness and implementation outcomes.
Read more
Quantitative data includes self-reported questionnaires, administrative data, a motor skill performance assessment and height and weight measurements to determine Body Mass Index (BMI). Data will be collected through self-reported questionnaires filled in by the parents of children who participate in 010 Fit'R. Additionally, children will be assessed on motor skills by providers of healthy lifestyle interventions involved in 010 Fit'R. Moreover, weight and height will be measured by the provider following standardized procedures. The parental questionnaire, motor skills and BMI will be assessed pre and post intervention. Administrative data includes data reported by providers on implementation outcomes, for example, data regarding enrolment and retention.
Qualitative data includes documentary evidence of each healthy lifestyle intervention involved in 010 Fit'R to assess 'effective components' of interventions. In addition, two workshops with providers and/or practitioners of interventions will be held to map the context, working elements and outcomes.
Focus groups (FGs) and semi-structured interviews are used to gather information from parents, children and providers and/or practitioners regarding implementation outcomes.
- Conditions
- Overweight, Children
- Being tested
- 010 Fit'R intervention
- Keywords
- overweight, children, lifestyle intervention
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
010 Fit'R interventionBehavioural
Within the policy framework of 010 Fit'R, 12 different healthy lifestyle interventions will be implemented for children with overweight. Children participate in one of the 12 interventions. All interventions consist of at least one physical activity each week and encouraging a healthy lifestyle in children, individually or in groups, and advising children and their parents on nutrition, exercise, motor skills, and sustainable behavioral change.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Children (4-12 years old) participate in one of 12 healthy lifestyle interventions focused on physical activity, nutrition and additional lifestyle factors Receives: Behavioral: 010 Fit'R intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS - assessed by a questionnaire
Health-related quality of life measured by the Patient-Reported Outcomes Measurement Information System
Measured: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Secondary outcomes (6)
BMI - assessed by physical measurement
Based on height and weight
Measured: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Motor skills - assessed by physical measurement
4 S-en test (Kernebeek et al., 2018)
Measured: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Nutrition - assessed by a questionnaire
Frequency of eating breakfast, fruit, vegetables, whole grain producents, sweet beverages, snacks
Measured: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Physical activity - assessed by a questionnaire
Frequency and duration of playing sports, playing outside, perception of physical behaviour
Measured: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Sleep behaviour - assessed by a questionnaire
General duration of sleep (hours) and sleep behaviour in the past 2 months
Measured: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Screen time - assessed by a questionnaire
General duration of screen time (hours) on weekdays and during weekends
Measured: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start11 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- No control group intervention trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilma Jansen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419503
- Sponsor's protocol ID
- 13555
- Acronym
- 010Fit'R
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 010 Fit'R 2025-2027: Approach for Children (4-12 Years Old) With Overweight
- ClinicalTrials.gov ID
- NCT07419503
- Acronym / sponsor ID
- 010Fit'R / 13555
- Conditions
- Overweight, Children
- Keywords
- overweight, children, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Feb 2026 (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.
Overweight is a leading risk factor for non-communicable diseases. In the Netherlands, about 11% of children aged 4-12 years are overweight. The causes of childhood overweight are multifaceted, involving (epi)genetic, environmental, socioeconomic, and behavioral factors. The societal consequences are far-reaching, including lower academic performance, reduced quality of life and a greater risk of developing obesity in adulthood.
Lifestyle interventions with diet and physical activity components have been shown to effectively reduce childhood overweight. The "010 Fit'R - Rotterdam approach for children with overweight" targets children between 4 and 12 years old and their parents. The program consists of multicomponent interventions addressing various lifestyle aspects, such as physical activity, nutrition, motor skills and healthy behaviours aiming to foster sustainable lifestyle changes. Providers were invited by the municipality of Rotterdam to develop interventions within the policy framework of 010 Fit'R. 12 providers were selected by the municipality based on the selection criteria (quality of the program; experience with the activities and target group; demonstrable connection with the area; connection with the target group; recruitment strategy; costs) and distributed over different neighbourhoods. This study evaluates the healthy lifestyle interventions involved in 010 Fit'R in terms of effectiveness and implementation outcomes.
Quantitative data includes self-reported questionnaires, administrative data, a motor skill performance assessment and height and weight measurements to determine Body Mass Index (BMI). Data will be collected through self-reported questionnaires filled in by the parents of children who participate in 010 Fit'R. Additionally, children will be assessed on motor skills by providers of healthy lifestyle interventions involved in 010 Fit'R. Moreover, weight and height will be measured by the provider following standardized procedures. The parental questionnaire, motor skills and BMI will be assessed pre and post intervention. Administrative data includes data reported by providers on implementation outcomes, for example, data regarding enrolment and retention.
Qualitative data includes documentary evidence of each healthy lifestyle intervention involved in 010 Fit'R to assess 'effective components' of interventions. In addition, two workshops with providers and/or practitioners of interventions will be held to map the context, working elements and outcomes.
Focus groups (FGs) and semi-structured interviews are used to gather information from parents, children and providers and/or practitioners regarding implementation outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No control group intervention trial
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: 010 Fit'R interventionChildren (4-12 years old) participate in one of 12 healthy lifestyle interventions focused on physical activity, nutrition and additional lifestyle factors |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child participates in the 010Fit'R program and is between 4 and 12 years old (at the start of recruitment)
- Parents of children participating in the 010 Fit'R program
- Provider (e.g. participate in interview) is actively involved in promoting, implementing or conducting a healthy lifestyle intervention funded by 010Fit'R
- All participants should be able to comprehend provided information to make an informed decision for participation and should provide consent for participating. In case of children the parent(s) consent, as well as the child when 12 years old.
Key exclusion criteria (1 listed)
- Outside of the age range, no consent for participation from provider, parent and/or child
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 |
|---|---|---|
| 010 Fit'R interventionWithin the policy framework of 010 Fit'R, 12 different healthy lifestyle interventions will be implemented for children with overweight. Children participate in one of the 12 interventions. All interventions consist of at least one physical activity each week and encouraging a healthy lifestyle in children, individually or in groups, and advising children and their parents on nutrition, exercise, motor skills, and sustainable behavioral change. | Behavioural | Lifestyle intervention |
Primary outcome
PROMIS - assessed by a questionnaire
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Health-related quality of life measured by the Patient-Reported Outcomes Measurement Information System
6 secondary outcomes
BMI - assessed by physical measurement
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Motor skills - assessed by physical measurement
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Nutrition - assessed by a questionnaire
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Physical activity - assessed by a questionnaire
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Sleep behaviour - assessed by a questionnaire
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Screen time - assessed by a questionnaire
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided. A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 010 Fit'R intervention in people with Overweight and Children, run by Erasmus Medical Center at 1 site in Netherlands.
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 4 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: enrolling by invitation, as of the sponsor's last update on 19 Feb 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
PROMIS - assessed by a questionnaire (time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2026.