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Published on: December 1, 2023
Randomised controlled trials in overweight children: practicalities and realities
Janet M Warren1, Rebecca K Golley, Clare E Collins
1University of Newcastle, Schools of Health Sciences and Education, Callaghan Campus, Newcastle, New South Wales, Australia. j.warren@uq.edu.au
Insights
Conducting high-quality randomised controlled trials (RCTs) with overweight and obese children requires careful planning. Strategies for recruitment, retention, and family engagement are crucial for successful interventions.
Area of Science:
- Pediatric obesity research
- Clinical trial methodology
Background:
- Three Australian interventions involving overweight/obese children provided practical insights.
- Key challenges include study design, ethical approval, outcome measures, recruitment, family engagement, and data management.
Purpose of the Study:
- To discuss practical aspects of conducting high-quality randomised controlled trials (RCTs) for pediatric obesity.
- To offer suggestions for researchers based on real-world intervention experiences.
Main Methods:
- Review of experiences from three Australian intervention studies.
- Identification and discussion of practical issues in pediatric RCTs.
Main Results:
- Multi-site trials enhance sample size and external validity despite higher costs.
- Common challenges in recruitment, retention, and family collaboration were identified.
Conclusions:
- Interventions for pediatric overweight/obesity are complex and require strategic approaches.
- Developed strategies address common RCT challenges, particularly recruitment, retention, and family engagement.
Aim:
To highlight and discuss the practical aspects of conducting high quality, randomised controlled trials (RCTs) with overweight and obese children and their families.
Content:
Realistic considerations and suggestions for researchers arising from the experiences of three Australian interventions in overweight/obese children are highlighted. The practical implications of key issues arising during this type of RCT include study design, obtaining ethical approval, choice of outcome measures, recruitment, working with families, impact and process evaluation, retention strategies, managing multi-site trials and data management.
Conclusion:
Interventions for overweight children and their families are challenging. Although there were some differences in the design and outcome measures among the three studies, there were many similarities. Multi-site trials, although more expensive than single-site trials, are advantageous in increasing sample size and external validity. Collectively we have developed strategies to address key problems in conducting RCTs, including the common challenges of recruitment, retention and working with families.
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