Testing Digital Technologies to Help Families Build Healthy Habits

• ClinicalTrials.gov Identifier: NCT04845568
• Recruitment Status: Recruiting
• First Posted: April 15, 2021
• Last Update Posted: February 22, 2022
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Behavioral: Virtual Reality Experience	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Masking Description: No masking. Outcomes will be assessed via surveys.
• Primary Purpose: Treatment
• Official Title: Testing Digital Technologies to Help Families Build Healthy Habits
• Actual Study Start Date: April 17, 2021
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Video; 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.
Experimental: Virtual Reality; 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; 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."

Outcome Measures

Primary Outcome Measures :

1. Acceptability as measured by the System Usability Scale [ Time Frame: Assessed immediately post intervention/control ]
   Assessed with the System Usability Scale adapted to be parent proxy-report for the child. The instrument measures usability. It consists of a 10 item questionnaire with five response options for respondents; from strongly disagree to strongly agree. It was originally created by John Brooke in 1986 to evaluation a wide variety of products and services.
2. Acceptability as measured by the Usefulness, Satisfaction and Ease of Use Questionnaire [ Time Frame: Assessed immediately post intervention/control ]
   Assessed with the Satisfaction and Ease of Use measure adapted to be parent proxy-report for the child. The instrument (Lund, 2001) measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction.
3. Acceptability as measured by degree of immersion (for those in the virtual reality condition) [ Time Frame: Assessed immediately post intervention ]
   Assessed by parent self-report with the Presence Questionnaire (Witmer 2005) immediately post intervention. The Presence Questionnaire assesses involvement, auditory fidelity, adaption/immersion, interface quality, consistency with expectations, and haptic/visual fidelity.
4. Acceptability as measured by child interview questions [ Time Frame: Assessed immediately post intervention/control ]
   Assessed with child interview questions created by the study team. Includes questions regarding what children liked and didn't like about the control and intervention conditions, how engaging they found the intervention/control, and if they found the intervention/control motivating. Questions are answered on a 5-point smiley face likert scale.
5. Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA) [ Time Frame: Immediately pre and post intervention/control ]
   Child self-report survey measure. The 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. The SE-HEPA is based on Bandura's (1977) social cognitive theory and was designed to evaluate a children's or adolescents' confidence in their ability to engage in healthy eating and physical activity behaviors. Items are answered on 5 point likert scales from strongly disagree to strongly agree.
6. Change in Readiness to Change Diet and Physical Activity [ Time Frame: Items are assessed immediately pre intervention/control and immediately post or at minimum 2-weeks after intervention/control depending on the item (some are administered immediately post, and some at minimum 2-week follow-up) ]
   The Readiness to Change Diet and Physical Activity Scale items used in Rhee et al.'s 2015 article were modeled from previously used questions and designed to categorize respondents into the five stages of change: pre-contemplation, contemplation, preparation, action and maintenance. Parents self-report on their intentions to help their children with healthy habits.
7. Change in Behavioral Beliefs and Intentions [ Time Frame: Immediately pre and post intervention/control, as well as at minimum 2 weeks after intervention/control ]
   Parent and Child self-report, attitudes, beliefs and intentions assessed by items based on the theory of planned behavior. Items are answered on 7 point likert scales from strongly disagree to strongly agree.

Secondary Outcome Measures :

1. Change in Behavior [ Time Frame: Immediately pre intervention/control and at minimum 2 weeks after intervention/control ]
   Parent proxy-report of eating and physical activity behavior assessed by weekly intake of fruits and vegetables, fast food, foods away from home, consumption of breakfast, screen time, and minutes of mild, moderate, and vigorous activity over the past week.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Melissa M Vazquez, BA; (314)-273-9187; melissavazquez@wustl.edu

Locations

United States, Missouri

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Melissa M Vazquez, BA 314-273-9187 melissavazquez@wustl.edu

Contact: Lauren A Fowler, PhD 3142860250 lauren.fowler@wustl.edu

Principal Investigator: Ellen E Fitzsimmons-Craft, PhD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

• Principal Investigator: Ellen E Fitzsimmons-Craft, PhD; Washington University Medical School

More Information

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04845568
• Other Study ID Numbers: 202004074
• First Posted: April 15, 2021
• Last Update Posted: February 22, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Consent to share data is collected and available upon reasonable request after the publication of main outcomes.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:

Virtual Reality; Obesity; Childhood Obesity

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight