Effectiveness of a Family Support Model for Prevention and Management of Overweight and Obesity in Children 6-12 Years
- Conditions
- Obesity &Amp; Overweight
- Registration Number
- NCT07158944
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
The study will evaluate a coherent model of family support including school health care, primary health care and pediatric clinics. The model combines two evidence based programs: the universal "A Healthy School Start" provided to all children and their families during grade 1 and the targeted parental support program "More and Less" provided to parents of children with overweight or obesity.
The hypothesis is that combining the Healthy School Start and More and Less programs in a coherent model will increase the collaboration between regional and municipal stakeholders, ensure early identification of families in need, ultimately improving prevention and treatment of childhood overweight and obesity. The aim of this study is to evaluate the implementation of a coherent model of family support provided through school and primary health care.
- Detailed Description
In this hybrid type 2 effectiveness-implementation study, a two-armed randomized controlled trial will randomize families to either the intervention arm receiving the More and Less program or the control arm receiving standard care from primary health care or a pediatric clinic. A matched control group will be identified from a national obesity register for supplementary comparison. Eligible participants are families with children aged 6-12 years with overweight or obesity, enrolled in schools implementing the Healthy School Start program. Effectiveness outcomes to evaluate the intervention are BMI z-score, parental feeding practices, diet and physical activity, child eating behaviour and intervention fidelity which will be measured at baseline, three and 12 months. Implementation outcomes will be evaluated in a process evaluation assessing reach, fidelity, acceptability, feasibility and cost, assessed at 12 and 24 months using a mixed methods approach.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 126
- A parent of a child between 6-12 years of age.
- The child attends a school providing the Healthy School Start program.
- The child has been diagnosed with overweight (BMI z-score ≥25) or obesity (BMI z-score ≥30) by a health care personnel.
- If parents are unable to understand and/or communicate in easy Swedish.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method BMI z-score Measured at baseline, 3 and 12 months. The effects on children's BMI z-score (IOTF cut offs) whose parents receive the More and Less program over a 12-month period, compared to children receiving standard treatment
- Secondary Outcome Measures
Name Time Method The child's physical activity level Measured at baseline, 3 and 12 months Assessed through three questions from the Public Health Agency's annual school survey to children, with questions asked to the parents
The child's dietary habits Measured at baseline, 3 and 12 months follow-up Assessed using the Eating and Physical Activity Questionnaire (EPAQ)
The child's eating behavior Measured at baseline, 3 and 12 months Assessed using the Children's Eating Behaviour Questionnaire (CEBQ) including questions that helps identify behavioral traits that may contribute to obesity or disordered eating and is answered by a parent
Parental feeding practices Measured at baseline, 3 and 12 months Assessed using the Comprehensive Parental Feeding Questionnaire (CPFQ) including five factors: Monitoring of children's food intake, pressure to eat, restriction of food, use of food for emotional regulation, and healthy eating guidance.
Trial Locations
- Locations (1)
Primary healthcare
🇸🇪Södertälje, Sweden
Primary healthcare🇸🇪Södertälje, Sweden