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

NCT07419503 | Enrolling By Invitation

• 1 other identifier: 13555
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight; Children

Keywords

overweight; children; lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• BMI - assessed by physical measurement

  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

  Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)

• Nutrition - assessed by a questionnaire

  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

  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

  Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)

Other Outcomes (2)

• Demographic variables - assessed by a questionnaire

  Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)

• Feasibility data on implementation outcomes

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

Study Arms (1)

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

Behavioral: 010 Fit'R intervention

Interventions

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.

Lifestyle intervention

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Outside of the age range, no consent for participation from provider, parent and/or child

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Department of Public Health, Erasmus MC University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: No control group intervention trial

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 19, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

NL (1)