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A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an
Anna Ek1, Christine Delisle Nyström2, Adela Chirita-Emandi3,4
1Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm, Sweden. anna.ek@ki.se.
Insights
This study evaluates a parent support program (More and Less) combined with an app (MINISTOP) to manage childhood obesity. The program aims to improve healthy eating and physical activity in young children.
Area of Science:
- Pediatric endocrinology
- Public health
- Behavioral science
Background:
- Childhood overweight and obesity is a growing public health concern, particularly in preschool-aged children.
- Effective, standardized treatments for childhood obesity are lacking, necessitating feasible approaches for families and healthcare providers.
- This study addresses the need for effective interventions by assessing a parent support program and a mobile health application.
Purpose of the Study:
- To evaluate the acceptance and effectiveness of the More and Less (ML) parent support program.
- To assess the impact of the MINISTOP mobile health application in managing childhood overweight and obesity.
- To investigate the program's feasibility in a socially diverse population across three European countries.
Main Methods:
- A randomized controlled trial involving 300 children aged 2-6 years with overweight/obesity in Romania, Spain, and Sweden.
- Intervention group received 10 weekly group sessions (ML program) followed by 6 months of the MINISTOP app.
- Primary outcome: change in body mass index (BMI) z-score at 9 months; secondary outcomes included various health behaviors, dietary patterns, and epigenetic markers.
Main Results:
- The study is designed to measure changes in BMI z-score, waist circumference, eating and parenting behaviors, physical activity, dietary patterns, and epigenetic markers.
- Data collection includes baseline, 10-week, 9-month, 15-month, and 21-month follow-ups.
- Acceptance will be assessed through semi-structured interviews with participating families.
Conclusions:
- The study will determine the effectiveness of a parent support program and a mobile health app for pediatric weight management.
- Successful outcomes could lead to the integration of this program into routine healthcare for young children.
- The MINISTOP app may offer a viable solution for maintaining long-term positive health behaviors.
Background:
Childhood overweight and obesity is a serious public health issue with an increase being observed in preschool-aged children. Treating childhood obesity is difficult and few countries use standardized treatments. Therefore, there is a need to find effective approaches that are feasible for both health care providers and families. Thus, the overall aim of this study is to assess the acceptance and effectiveness of a parent support program (the More and Less, ML) for the management of overweight and obesity followed by a mobile health (mHealth) program (the MINISTOP application) in a socially diverse population of families.
Methods/Design:
A two-arm, parallel design randomized controlled trial in 300 2-to 6-year-old children with overweight and obesity from Romania, Spain and Sweden (n = 100 from each). Following baseline assessments children are randomized into the intervention or control group in a 1:1 ratio. The intervention, the ML program, consists of 10-weekly group sessions which focus on evidence-based parenting practices, followed by the previously validated MINISTOP application for 6-months to support healthy eating and physical activity behaviors. The primary outcome is change in body mass index (BMI) z-score after 9-months and secondary outcomes include: waist circumference, eating behavior (Child Eating Behavior Questionnaire), parenting behavior (Comprehensive Feeding Practices Questionnaire), physical activity (ActiGraph wGT3x-BT), dietary patterns (based on metabolic markers from urine and 24 h dietary recalls), epigenetic and gut hormones (fasting blood samples), and the overall acceptance of the overweight and obesity management in young children (semi-structured interviews). Outcomes are measured at baseline and after: 10-weeks (only BMI z-score, waist circumference), 9-months (all outcomes), 15- and 21-months (all outcomes except physical activity, dietary patterns, epigenetics and gut hormones) post-baseline.
Discussion:
This study will evaluate a parent support program for weight management in young children in three European countries. To boost the effect of the ML program the families will be supported by an app for 6-months. If the program is found to be effective, it has the potential to be implemented into routine care to reduce overweight and obesity in young children and the app could prove to be a viable option for sustained effects of the care provided.
Trial Registration:
ClinicalTrials.gov NCT03800823; 11 Jan 2019.
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