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Process Evaluation of a Randomized Controlled Trial With a Mobile Health Intervention for Children With Obesity
Linnea Hedin1,2, Maria Hagströmer3,4,5, Claude Marcus1
1Department of Clinical Science, Intervention and Technology, Division of Pediatrics, Karolinska Institutet, Stockholm, Sweden.
Sage Open Pediatrics
|July 4, 2025
Summary
Recruitment and retention in pediatric obesity trials are challenging due to technical issues and participant engagement. Improving mobile health (mHealth) interventions requires addressing these barriers for better outcomes.
Area of Science:
- Pediatric Obesity Treatment
- Digital Health Interventions
- Clinical Trial Management
Background:
- Mobile health (mHealth) interventions offer potential for pediatric obesity treatment.
- Understanding barriers in randomized controlled trials (RCTs) is crucial for successful implementation.
Purpose of the Study:
- To identify barriers to recruitment, attrition, and mHealth usage in a Swedish pediatric obesity RCT.
- To evaluate these barriers using Normalization Process Theory (NPT).
Main Methods:
- Retrospective process evaluation of an mHealth intervention for children aged 5-12.
- Data collected on staff/parental mHealth experience, usage, staff time, recruitment, and attrition.
- Analysis aligned with NPT constructs.
Main Results:
- Complex recruitment, with summer enrollment impacting engagement.
- Attrition linked to technical issues, low motivation, and dislike of the mHealth intervention.
- Technical problems were the primary barrier to mHealth use; staff found the intervention time-consuming and difficult to understand.
Conclusions:
- Findings highlight key challenges in pediatric mHealth RCTs.
- Suggests strategies to improve recruitment, retention, and mHealth adoption in future trials.
- Addressing technical and engagement barriers is vital for effective pediatric obesity interventions.
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