Testing Digital Technologies to Help Families Build Healthy Habits

Childhood Obesity Clinical Trial

Official title:

Testing Digital Technologies to Help Families Build Healthy Habits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845568
• Other study ID #: 202004074
• Status: Completed
• Phase: N/A
• Start date: April 17, 2021
• Est. completion date: May 7, 2022

Study information

• Verified date: May 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 7, 2022
• Est. primary completion date: May 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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."

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability as measured by the System Usability Scale	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.	Assessed immediately post intervention/control
Primary	Acceptability as measured by the Usefulness, Satisfaction and Ease of Use Questionnaire	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.	Assessed immediately post intervention/control
Primary	Acceptability as measured by degree of immersion (for those in the virtual reality condition)	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.	Assessed immediately post intervention
Primary	Acceptability as measured by child interview questions	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.	Assessed immediately post intervention/control
Primary	Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)	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.	Immediately pre and post intervention/control
Primary	Change in Readiness to Change Diet and Physical Activity	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.	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)
Primary	Change in Behavioral Beliefs and Intentions	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.	Immediately pre and post intervention/control, as well as at minimum 2 weeks after intervention/control
Secondary	Change in Behavior	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.	Immediately pre intervention/control and at minimum 2 weeks after intervention/control