010Fit'R - Healthy Lifestyle Interventions for Children With Overweight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 010 Fit'R intervention.
- Who it may be relevant to
- Registry conditions: Overweight, Children. Basic parameters: 4 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
010 Fit'R 2025-2027: Approach for Children (4-12 Years Old) With Overweight
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Secondary outcome measures (6)
- 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)]
Eligibility criteria
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
- 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.
Exclusion criteria
- Outside of the age range, no consent for participation from provider, parent and/or child
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Netherlands · 1 center
- Department of Public Health, Erasmus MC University Medical Center — Rotterdam
Identifiers
NCT: NCT07419503 · 13555