010 Fit'R 2025-2027: Approach for Children (4-12 Years Old) With Overweight
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- PROMIS - assessed by a questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Outside of the age range, no consent for participation from provider, parent and/or child
研究组 & 干预措施
Lifestyle intervention
Children (4-12 years old) participate in one of 12 healthy lifestyle interventions focused on physical activity, nutrition and additional lifestyle factors
干预措施: 010 Fit'R intervention (Behavioral)
结局指标
主要结局
PROMIS - assessed by a questionnaire
时间窗: 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
次要结局
- 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))
- Screen time - assessed by a questionnaire(Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks))
研究者
Wilma Jansen
Senior researcher
Erasmus Medical Center