Testing Digital Technologies to Help Families Build Healthy Habits

NCT04845568 | Completed Results

• 1 other identifier: 202004074
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Virtual Reality; Obesity; Childhood Obesity

Outcome Measures

Primary Outcomes (7)

• Acceptability as Measured by the System Usability Scale

  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,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall score."

  Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention

• Acceptability as Measured by the Usefulness, Satisfaction and Ease of Use Questionnaire

  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 indicating greater usability.

  Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention

• Acceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)

  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 from 23 to 161, with greater scores indicating greater self-reported feelings of being immersed in the virtual environment.

  Assessed immediately after the 10-minute, single-session, in-person virtual reality intervention

• Acceptability as Measured by Child Interview Questions

  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.

  Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention

• Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)

  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 create two subscales: self-efficacy for healthy eating, and self-efficacy for physical activity. Possible scores for each subscale range from 8 to 40, with greater scores indicating greater self-efficacy.

  Assessed at baseline (before the intervention) and immediately after the 10-minute, single-session, in-person virtual reality or video intervention

• Change in Caregiver Readiness to Change Diet and Physical Activity

  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 intend to make changes in the next month"), to 4 ("I'm already helping my child improve their \[eating/activity\]"). Scores range from 1 to 4, with greater scores indicating greater caregiver readiness to help their child change. Items are not aggregated, and each item is analyzed separately.

  Items are assessed immediately pre intervention and at 2-weeks after intervention

• Change in Behavioral Beliefs (Attitudes) and Intentions

  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 from 8 to 56, and greater scores indicating more positive attitudes toward eating healthier. Six items measured child intentions toward healthy eating, with total scores ranging 6 to 42, and greater scores indicating greater intentions to engage in the behavior. Four items measured caregiver intentions to help child, with total scores ranging from 4 to 28, and greater scores indicating gre

  At baseline and after the 10-minute, single-session, in-person intervention

Secondary Outcomes (3)

• Change in Child Diet

  Immediately pre intervention/control and at 2 week follow-up

• Change in Child Eating Behavior

  Immediately pre intervention/control and at 2 week follow-up

• Change in Screen Time and Activity Behavior

  Immediately pre intervention/control and at 2 week follow-up

Study Arms (2)

Video

NO INTERVENTION

This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.

Virtual Reality

EXPERIMENTAL

This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences.

Behavioral: Virtual Reality Experience

Interventions

Virtual Reality Experience BEHAVIORAL

The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."

Virtual Reality

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Fowler LA, Vazquez MM, DePietro B, Wilfley DE, Fitzsimmons-Craft EE. Development, usability, and preliminary efficacy of a virtual reality experience to promote healthy lifestyle behaviors in children: pilot randomized controlled trial. Mhealth. 2024 Oct 21;10:29. doi: 10.21037/mhealth-24-24. eCollection 2024.

  PMID: 39534453 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ellen Fitzsimmons-Craft
• Organization: Washington University

fitzsimmonse@wustl.edu

3142862074

Study Officials

• Ellen E Fitzsimmons-Craft, PhD

  Washington University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking. Outcomes will be assessed via surveys.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: April 15, 2021
• Study Start: April 17, 2021
• Primary Completion: May 7, 2022
• Study Completion: May 7, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)