N/A N=54 Randomized Treatment

Testing Digital Technologies to Help Families Build Healthy Habits

Childhood Obesity

Bottom Line

View on ClinicalTrials.gov: NCT04845568 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Sep 2024

Primary outcome: Primary: Acceptability as Measured by the System Usability Scale — 80.63; 76.54 scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Virtual Reality Experience (Behavioral)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Acceptability as Measured by the System Usability Scale	80.63; 76.54	—
PRIMARY Acceptability as Measured by the Usefulness, Satisfaction and Ease of Use Questionnaire	75.58; 79.31	—
PRIMARY Acceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)	116.92	—
PRIMARY Acceptability as Measured by Child Interview Questions	3.54; 4.31; 4.08; 3.69	—
PRIMARY Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)	26.08; 26.64; 28.69; 28.07; 24.08; 23.64	0.592
PRIMARY Change in Caregiver Readiness to Change Diet and Physical Activity	3.15; 3.43; 3.31; 3.86; 3.08; 3.29	.368
PRIMARY Change in Behavioral Beliefs (Attitudes) and Intentions	27.62; 25.14; 31.46; 27; 21.31; 19.36	.783
SECONDARY Change in Child Diet	3.23; 3.50; 2.85; 3.5; 2; 2.14	.547
SECONDARY Change in Child Eating Behavior	4.54; 4.93; 5.54; 5.86; 5.77; 5.93	.777
SECONDARY Change in Screen Time and Activity Behavior	4.31; 4.11; 2.35; 2.89; 3.35; 3.61	.086

Summary

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.

Eligibility Criteria

This study is enrolling guardian and child dyads.

Eligibility criteria include:

Parent is biological or legal guardian and can therefore consent on behalf of the child
Parent is under 80 years old and child is between 6 and 12 years old
Child BMI is at or above the 85th percentile for age and sex
Parent BMI is at or above 25

Exclusion Criteria include:

Child is in behavioral weight-loss treatment (behavior weight-loss treatment will not include if their pediatrician is counseling them on their weight, but instead refers to intensive outpatient behavioral treatment for overweight/obesity only) 6. Child or parent have a history of seizures, a history of severe psychiatric conditions such as Schizophrenia or Paranoia, or use any medical devices such as pacemakers 7. Child is exhibiting any disordered eating behavior (i.e. purging, laxative or diuretic use)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04845568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.