Virtual reality (VR) shows promise for supporting behavior change in children. This study used user-centered design to translate key tenets of behavioral health interventions into VR for children aged 6-12 years and their caregivers and examined the feasibility, acceptability, and preliminary efficacy of the VR experience in a pilot parallel, two-group randomized controlled trial (RCT). The VR experience incorporates psychoeducational content from evidence-based behavioral health interventions using voiceover and an interactive go-kart game related to the concepts of "food as fuel" and nutrition guidelines. Study 1 involved usability testing with n=5 child-caregiver dyads, which informed technical and content refinements to the experience. Study 2 involved children aged 6-12 years with body mass index (BMI) ≥85th percentile for age and sex who were comfortable speaking English and their caregivers with BMI ≥25 kg/m2. After participants completed baseline assessments in lab on eating-related behavioral cognitions and behaviors, participants were randomly assigned to the 10-minute VR experience or a control condition (i.e., nutrition education video and mobile phone food game), and were unblinded to condition. Child and caregivers completed assessments immediately post-intervention (eating-related behavioral cognitions) and at 2-week follow-up (behaviors, caregiver readiness to change). The objectives were to evaluate the feasibility, usability, and acceptability of the VR experience, and examine the preliminary efficacy of VR compared to the control condition on the primary outcomes of child behavioral cognitions and behaviors. Non-parametric tests examined differences in change scores across conditions as well as overall and within-group changes in outcomes. Twenty-seven child-caregiver dyads (14 in VR, 13 in control) were enrolled (child mean age =10.4 years; 14 girls). Caregivers reported good usability and excellent immersion in the virtual environment. Children reported significantly greater acceptability of VR compared to control (P=0.02). Child self-efficacy for healthy eating, self-efficacy for physical activity, attitudes toward healthy eating, and behavioral intentions for healthy eating increased from pre- to post-test in both conditions. From baseline to 2-week follow-up, all children reported greater weekly vegetable servings and more active days in the past week. Children in the VR condition had greater change in attitudes towards healthy eating from pre- to post-test compared to children in the control condition [effect size r=0.44, 95% confidence interval (CI): 0.03-0.72]. Readiness to help child change significantly increased for caregivers in the VR condition from pre- to 2-week follow-up, but did not change for caregivers in the control condition. No adverse events were reported. A VR program to promote healthy eating among children shows high feasibility and acceptability, and high potential for improving child and caregiver behavioral cognitions in this pilot RCT. Future work should examine the impact of repeated exposure to the experience over time, and examine long-term effects. ClinicalTrials.gov Identifier: NCT04845568.
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