Adults 6 to 80, any sex, with Childhood Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Acceptability as Measured by the System Usability ScalePrimary· Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
The System Usability Scale (SUS) was used to measure usability of the intervention. The items were adapted so that the caregiver could report on their child's experience of usability. SUS consists of 10 items with five response options on a Likert scale: strongly disagree (0) to strongly agree (4). SUS yields a single number representing a composite measure of the overall usability of a system being studied, ranging from 1 to 100, with greater scores reflecting greater usability, and calculated as follows (Brooke, 1996): "Each item's score contribution will range from 0 to 4. For items 1,3,5,7
Group
Value
95% CI
Video
80.63
± 10.72
Virtual Reality
76.54
± 17.66
Acceptability as Measured by the Usefulness, Satisfaction and Ease of Use QuestionnairePrimary· Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
The Usefulness, Satisfaction and Ease of Use Questionnaire was used to measure acceptability, specifically usefulness, ease of use, ease of learning, and satisfaction with an intervention or service. Items were adapted to have the caregivers report on their child's experience of usability. The shortened instrument used in this study (Lund, 2001) contains 19 items, and respondents indicate their agreement with each statement on a scale from 1 (strongly disagree) to 7 (strongly agree). Scores are summed to create an overall score of usability, ranging from 19 to 133, with greater scores indicati
Group
Value
95% CI
Video
75.58
± 12.67
Virtual Reality
79.31
± 15.67
Acceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)Primary· Assessed immediately after the 10-minute, single-session, in-person virtual reality intervention
Degree of Immersion in the virtual environment is assessed by parent self-report with the Presence Questionnaire (Witmer 2005). The Presence Questionnaire is a 24 item questionnaire that assesses involvement, auditory fidelity, adaption/immersion, interface quality, consistency with expectations, and haptic/visual fidelity. Given that sense of touch was not applicable to the present study, this item (23) was not included in the final score. Responses to the items are on a scale from 1 (not at all) to 7 (completely), and responses are summed to create an overall score. Potential scores range fr
Group
Value
95% CI
Virtual Reality
116.92
± 20.22
Acceptability as Measured by Child Interview QuestionsPrimary· Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
Assessed with child interview questions created by the study team. Questions ask children to respond by indicating which smiley face on a 5 point analog scale best represents how they feel, from 1 (unhappy/not at all) to 5 (very happy/a lot). Acceptability was assessed by asking how much the child liked the intervention, and motivation was assessed by asking the child how motivated they are to eat healthier post-intervention. Greater numbers on each question represent greater acceptability and greater post-intervention motivation, respectively.
Acceptability (1 question)
Group
Value
95% CI
Video
3.54
± 0.84
Virtual Reality
4.31
± 0.48
Motivating (1 question)
Group
Value
95% CI
Video
4.08
± 1.00
Virtual Reality
3.69
± .86
Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Primary· Assessed at baseline (before the intervention) and immediately after the 10-minute, single-session, in-person virtual reality or video intervention
Child self-report survey measure. The Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA) measure was developed by Steele, Bindler, Power, and Daratha (2008) and is based on Motl et al.'s (2000) unidimensional measure of self-efficacy for exercise. Based on Bandura's (1977) social cognitive theory, SE-HEPA was designed to evaluate a children's or adolescents' confidence in their ability to engage in healthy eating (8 items) and physical activity behaviors (8 items). Items are answered on 5 point Likert scales from strongly disagree (1) to strongly agree (5). Scores are summed to c
Pre-intervention healthy eating
Group
Value
95% CI
Video
26.08
± 9.68
Virtual Reality
26.64
± 6.87
Post-intervention healthy eating
Group
Value
95% CI
Video
28.69
± 9.89
Virtual Reality
28.07
± 7.89
Pre-intervention Physical Activity
Group
Value
95% CI
Video
24.08
± 7.32
Virtual Reality
23.64
± 8.05
Post-intervention Physical Activity
Group
Value
95% CI
Video
26.23
± 9.37
Virtual Reality
26.93
± 7.73
Change in Caregiver Readiness to Change Diet and Physical ActivityPrimary· Items are assessed immediately pre intervention and at 2-weeks after intervention
The caregiver Readiness to Change Diet and Physical Activity items were adapted from previously used questions and designed to assess caregiver readiness to help their child change physical activity and eating behaviors. Parents self-report their intentions to help their children with healthy habits by answering "Do you intend to find ways to improve the way your child eats?" and "Do you intend to find ways to improve your child's physical activity level?" with responses from 1 ("No, and I'm not intending to make changes"), 2 ("Yes, I intend to make changes in the next 6 months"), 3 ("Yes, I i
Pre-intervention intend to help child change eating
Group
Value
95% CI
Video
3.15
± .80
Virtual Reality
3.43
± .51
Two-week post-intervention intend to help child change eating
Group
Value
95% CI
Video
3.31
± .86
Virtual Reality
3.86
± .36
Pre-intervention intend to help child change activity
Group
Value
95% CI
Video
3.08
± .86
Virtual Reality
3.29
± .73
Two-week Post-intervention intend to help child change activity
Group
Value
95% CI
Video
3.31
± .95
Virtual Reality
3.64
± .63
Change in Behavioral Beliefs (Attitudes) and IntentionsPrimary· At baseline and after the 10-minute, single-session, in-person intervention
Behavioral beliefs (attitudes) and intentions toward health eating were measured with items adapted from previous literature based on the Theory of Planned Behavior. Where needed, language was adapted to lower the reading level for child participants. Items were answered on 7 point Likert scales from strongly disagree (1) to strongly agree (7). Scores were summed for child attitudes (beliefs), child intentions, and caregiver intentions, self-reported by children and caregivers pre- and post-intervention. Eight items measured child attitudes towards eating healthy, with total scores ranging fro
Change in Child DietSecondary· Immediately pre intervention/control and at 2 week follow-up
Parents reported on their child's eating behavior of the previous week with three different items asking parents to report the number of servings per week the child ate of fruits, vegetables, and fast foods.
Pre-intervention Weekly intake of fruits
Group
Value
95% CI
Video
3.23
± 1.42
Virtual Reality
3.50
± 1.09
Pre-intervention Weekly intake of vegetables
Group
Value
95% CI
Video
2.85
± .9
Virtual Reality
3.5
± .86
Pre-intervention Weekly intake of fast foods
Group
Value
95% CI
Video
2
± .58
Virtual Reality
2.14
± 1.1
Two-week Post-intervention Weekly intake of fruits
Group
Value
95% CI
Video
2.77
± 1.30
Virtual Reality
3.29
± 1.07
Two-week Post-intervention Weekly intake of vegetables
Group
Value
95% CI
Video
2.92
± 1.12
Virtual Reality
3.57
± 0.94
Two-week Post-intervention Weekly intake of fast food
Group
Value
95% CI
Video
1.85
± .56
Virtual Reality
1.79
± .7
Change in Child Eating BehaviorSecondary· Immediately pre intervention/control and at 2 week follow-up
Parents reported on their child's eating behavior of the previous week with two different items asking parents to report the number of days per week the child ate breakfast and family dinner.
Pre-intervention family dinner
Group
Value
95% CI
Video
4.54
± 2.11
Virtual Reality
4.93
± 2.50
Pre-intervention intake of breakfast
Group
Value
95% CI
Video
5.54
± 1.61
Virtual Reality
5.86
± 1.66
Two-week Post-intervention Weekly intake of breakfast
Group
Value
95% CI
Video
5.77
± 1.64
Virtual Reality
5.93
± .92
Two-week Post-intervention Weekly intake of family dinner
Group
Value
95% CI
Video
4.85
± 1.72
Virtual Reality
4.5
± 2.03
Change in Screen Time and Activity BehaviorSecondary· Immediately pre intervention/control and at 2 week follow-up
Parents reported on their child's activity behavior of the previous week with two different items asking parents to report the average number of hours per day the child engaged in screen time and physical activity, on a scale from 1 to 5, with 1 = none; 2 = less than 1 hour per day; 3 = 1 to 2 hours per day; 4 = 3 to 4 hours per day; 5 = more than 4 hours per day.
Pre-intervention screen time
Group
Value
95% CI
Video
4.31
± .88
Virtual Reality
4.11
± 1.02
Pre-intervention active hours
Group
Value
95% CI
Video
2.35
± .72
Virtual Reality
2.89
± .66
Two-week Post-intervention screen time
Group
Value
95% CI
Video
3.35
± 1.05
Virtual Reality
3.61
± 1.20
Two-week Post-intervention active hours
Group
Value
95% CI
Video
2.54
± .80
Virtual Reality
2.96
± .46
Sponsor's own description
The current study is a randomized pilot trial to test the feasibility of a psychoeducational virtual reality experience to increase motivation for behavior change among children with overweight or obesity.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04845568.