Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07419503

010Fit'R - Healthy Lifestyle Interventions for Children 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.

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health, Erasmus MC University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

010 Fit'R intervention

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. 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)

    Based on height and weight

  2. 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)

    4 S-en test (Kernebeek et al., 2018)

  3. 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)

    Frequency of eating breakfast, fruit, vegetables, whole grain producents, sweet beverages, snacks

  4. 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)

    Frequency and duration of playing sports, playing outside, perception of physical behaviour

  5. 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)

    General duration of sleep (hours) and sleep behaviour in the past 2 months

  6. 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)

    General duration of screen time (hours) on weekdays and during weekends

Other outcomes

  1. Demographic variables - 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)

    Age, gender, living situation, country of birth, income and education level of parents

  2. Feasibility data on implementation outcomes

    Time frame: At the end of an intervention (depending on intervention at 12 to 40 weeks)

    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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

010 Fit'R 2025-2027: Approach for Children (4-12 Years Old) With Overweight

Acronym: 010Fit'R

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.