An interventional study of 010 Fit'R intervention in Overweight and Children, sponsored by Erasmus Medical Center. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Prevention
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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Providers of the interventions will recruite children (4-12 years old) with overweight to participate in their intervention. All children (and their parents) participating in the interventions are invited to participate in the evaluation research study.
Inclusion Criteria:
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.
Exclusion Criteria:
Children (4-12 years old) participate in one of 12 healthy lifestyle interventions focused on physical activity, nutrition and additional lifestyle factors
Behavioral: 010 Fit'R intervention
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.
PROMIS - assessed by a questionnaire
Health-related quality of life measured by the Patient-Reported Outcomes Measurement Information System
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
BMI - assessed by physical measurement
Based on height and weight
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
4 S-en test (Kernebeek et al., 2018)
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
Frequency of eating breakfast, fruit, vegetables, whole grain producents, sweet beverages, snacks
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
Frequency and duration of playing sports, playing outside, perception of physical behaviour
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
General duration of sleep (hours) and sleep behaviour in the past 2 months
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
General duration of screen time (hours) on weekdays and during weekends
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Demographic variables - assessed by a questionnaire
Age, gender, living situation, country of birth, income and education level of parents
Time frame: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)
Feasibility data on implementation outcomes
Feasibility data on implementation outcomes (e.g. reach, adoption, implementation, sustainability) will be collected through questionnaires for parents, focus groups with children and parents, administrative data and interviews with providers
Time frame: At the end of an intervention (depending on intervention at 12 to 40 weeks)
Plan to share: 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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