Clinical trial NCT04845568: Testing Digital Technologies to Help Families Build Healthy Habits
Official title: Testing Digital Technologies to Help Families Build Healthy Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Virtual Reality
Obesity
Childhood Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to control or intervention. The control condition is watching a video and playing a brief computer game, while the intervention condition consists of the virtual reality experience. Each provides child-friendly nutrition education as well as education on consideration of future consequences.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators will be conducting a randomized pilot trial to compare a virtual reality (VR) experience to a video. Each provides child-friendly nutrition education as well as education on consideration of future consequences (episodic future thinking). The video acts as the control condition such that we might begin to understand whether the psychological presence produced by virtual reality might increase motivation for behavior change.

The VR experience consists of a game in which participants play a racing game collecting healthy or unhealthy foods on the road. Collection of healthy foods increases speed, and collection of unhealthy foods decreases speed. Participants then play in the "future" where the food choices they made in the past also affect how they can move in the future game. If they collected mostly unhealthy foods in the past they move slower in the future, and if they collected healthy foods in the past they move faster in the future. However, foods collected in the future game can also change their speed, and participants are able to experience both future conditions i.e. they play in the future condition depending on if they ate healthily or not in the past, and then they play in the opposite future condition. A narrator in the game provides information on making healthy choices and about considering future consequences. The control video covers similar education on making healthy choices and considering future consequences. Additionally, the control video condition also includes a short computer-based game about healthy eating.

The investigators will enroll 60 English-speaking children ages 6-12 with overweight or obesity who are not in behavioral treatment to address weight and one of their parents. Participants will be recruited from the community using methods such as social media and flyers and will complete a phone-screen to determine initial eligibility. Participants determined to be eligible over the phone will come for an in-lab visit. In-lab, children will provide verbal assent and parents provide written informed consent. Children and parents will complete baseline measures, including having height and weight taken, demographic survey questions, assessment of participants' eating and physical activity behaviors, and other survey assessments selected to evaluate participants' behavioral beliefs, behavioral intentions, affect, and motivation for behavior change. Post-video or -VR participants will take the same survey assessments aimed at evaluating behavioral beliefs, intentions, affect and motivation for behavior change. Additionally, all participants will take usability assessments to determine the acceptability of the video or VR and participants randomized to the VR will complete measures to evaluate how immersive the VR seemed. At 2-week follow-up participants will again report their eating and physical activity behaviors and some cognitive measures in order to see whether the VR may have impacted behavior and cognitions.

Eligibility criteria: This study is enrolling guardian and child dyads.

Eligibility criteria include:

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

Exclusion Criteria include:

1. 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)

Primary outcomes:
measure: Acceptability as Measured by the System Usability Scale
timeFrame: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
measure: Acceptability as Measured by the Usefulness, Satisfaction and Ease of Use Questionnaire
timeFrame: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
measure: Acceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)
timeFrame: Assessed immediately after the 10-minute, single-session, in-person virtual reality intervention
measure: Acceptability as Measured by Child Interview Questions
timeFrame: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
measure: Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)
timeFrame: Assessed at baseline (before the intervention) and immediately after the 10-minute, single-session, in-person virtual reality or video intervention
measure: Change in Caregiver Readiness to Change Diet and Physical Activity
timeFrame: Items are assessed immediately pre intervention and at 2-weeks after intervention
measure: Change in Behavioral Beliefs (Attitudes) and Intentions
timeFrame: At baseline and after the 10-minute, single-session, in-person intervention
Secondary outcomes:
measure: Change in Child Diet
timeFrame: Immediately pre intervention/control and at 2 week follow-up
measure: Change in Child Eating Behavior
timeFrame: Immediately pre intervention/control and at 2 week follow-up
measure: Change in Screen Time and Activity Behavior
timeFrame: Immediately pre intervention/control and at 2 week follow-up
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University Medical School
name: Ellen E Fitzsimmons-Craft, PhD
role: PRINCIPAL_INVESTIGATOR
References: