010Fit'R - Healthy Lifestyle Interventions for Children With Overweight (010Fit'R)

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.

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 Overview

• Status: Enrolling by invitation
• Conditions: Overweight; Children
• Intervention / Treatment: Behavioral: 010 Fit'R intervention

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015GD
      • Department of Public Health, Erasmus MC University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lifestyle intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS - assessed by a questionnaire	Health-related quality of life measured by the Patient-Reported Outcomes Measurement Information System	Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI - assessed by physical measurement	Based on height and weight	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)	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	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	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	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	Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic variables - assessed by a questionnaire	Age, gender, living situation, country of birth, income and education level of parents	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	At the end of an intervention (depending on intervention at 12 to 40 weeks)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: overweight; children; lifestyle intervention
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight
• Other Study ID Numbers: 13555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No