Skip to content

Testing Digital Technologies to Help Families Build Healthy Habits

Testing Digital Technologies to Help Families Build Healthy Habits

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04845568
Enrollment
54
Registered
2021-04-15
Start date
2021-04-17
Completion date
2022-05-07
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

Virtual Reality, Obesity, Childhood Obesity

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.

Interventions

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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking. Outcomes will be assessed via surveys.

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 80 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Behavioral Beliefs (Attitudes) and IntentionsAt baseline and after the 10-minute, single-session, in-person interventionBehavioral 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
Acceptability as Measured by Child Interview QuestionsAssessed immediately after the 10-minute, single-session, in-person virtual reality or video interventionAssessed 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.
Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Assessed at baseline (before the intervention) and immediately after the 10-minute, single-session, in-person virtual reality or video interventionChild 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.
Change in Caregiver Readiness to Change Diet and Physical ActivityItems are assessed immediately pre intervention and at 2-weeks after interventionThe 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.
Acceptability as Measured by the System Usability ScaleAssessed immediately after the 10-minute, single-session, in-person virtual reality or video interventionThe 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.
Acceptability as Measured by the Usefulness, Satisfaction and Ease of Use QuestionnaireAssessed immediately after the 10-minute, single-session, in-person virtual reality or video interventionThe 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.
Acceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)Assessed immediately after the 10-minute, single-session, in-person virtual reality interventionDegree 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.

Secondary

MeasureTime frameDescription
Change in Child Eating BehaviorImmediately pre intervention/control and at 2 week follow-upParents reported on their child's eating behavior of the previous week with two different items asking parents to report the number of days per week the child ate breakfast and family dinner.
Change in Screen Time and Activity BehaviorImmediately pre intervention/control and at 2 week follow-upParents reported on their child's activity behavior of the previous week with two different items asking parents to report the average number of hours per day the child engaged in screen time and physical activity, on a scale from 1 to 5, with 1 = none; 2 = less than 1 hour per day; 3 = 1 to 2 hours per day; 4 = 3 to 4 hours per day; 5 = more than 4 hours per day.
Change in Child DietImmediately pre intervention/control and at 2 week follow-upParents reported on their child's eating behavior of the previous week with three different items asking parents to report the number of servings per week the child ate of fruits, vegetables, and fast foods.

Countries

United States

Participant flow

Participants by arm

ArmCount
Video (Children)
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.
13
Virtual Reality (Children)
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. 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.
14
Video (Caregivers)
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.
13
Virtual Reality (Caregivers)
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. 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.
14
Total54

Baseline characteristics

CharacteristicVideo (Children)TotalVirtual Reality (Caregivers)Video (Caregivers)Virtual Reality (Children)
Age, Continuous10.02 years
STANDARD_DEVIATION 2.21
27.43 years
STANDARD_DEVIATION 19.74
43.71 years
STANDARD_DEVIATION 8.29
45.31 years
STANDARD_DEVIATION 6.07
10.66 years
STANDARD_DEVIATION 1.51
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants0 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants50 Participants14 Participants11 Participants14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants13 Participants4 Participants2 Participants5 Participants
Race (NIH/OMB)
More than one race
2 Participants4 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
9 Participants35 Participants9 Participants10 Participants7 Participants
Region of Enrollment
United States
13 Participants54 Participants14 Participants13 Participants14 Participants
Sex: Female, Male
Female
6 Participants36 Participants12 Participants10 Participants8 Participants
Sex: Female, Male
Male
7 Participants18 Participants2 Participants3 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

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

Population: Data were reported by the child only. This item was not collected from caregivers.

ArmMeasureGroupValue (MEAN)Dispersion
VideoAcceptability as Measured by Child Interview QuestionsAcceptability (1 question)3.54 score on a scaleStandard Deviation 0.84
VideoAcceptability as Measured by Child Interview QuestionsMotivating (1 question)4.08 score on a scaleStandard Deviation 1
Virtual RealityAcceptability as Measured by Child Interview QuestionsAcceptability (1 question)4.31 score on a scaleStandard Deviation 0.48
Virtual RealityAcceptability as Measured by Child Interview QuestionsMotivating (1 question)3.69 score on a scaleStandard Deviation 0.86
Primary

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.

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

Population: Data were collected in Virtual Reality condition only. Data were reported by the caregivers, who reported for both the child and themselves. Only one score is reported for each child-caregiver dyad.

ArmMeasureValue (MEAN)Dispersion
Virtual RealityAcceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)116.92 score on a scaleStandard Deviation 20.22
Primary

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.

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

Population: Data were reported by the caregivers, who reported for both the child and themselves. Only one score is reported for each child-caregiver dyad.

ArmMeasureValue (MEAN)Dispersion
VideoAcceptability as Measured by the System Usability Scale80.63 scores on a scaleStandard Deviation 10.72
Virtual RealityAcceptability as Measured by the System Usability Scale76.54 scores on a scaleStandard Deviation 17.66
Primary

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.

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

Population: Data were reported by the caregivers, who reported for both the child and themselves. Only one score is reported for each child-caregiver dyad.

ArmMeasureValue (MEAN)Dispersion
VideoAcceptability as Measured by the Usefulness, Satisfaction and Ease of Use Questionnaire75.58 score on a scaleStandard Deviation 12.67
Virtual RealityAcceptability as Measured by the Usefulness, Satisfaction and Ease of Use Questionnaire79.31 score on a scaleStandard Deviation 15.67
Primary

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

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

Population: The outcome measures were analyzed separately for children and caregivers. Data below was collected by either the child only or the caregiver only, as indicated in the row title. Different measures were collected for children and caregivers, as indicated in the measure description.

ArmMeasureGroupValue (MEAN)Dispersion
VideoChange in Behavioral Beliefs (Attitudes) and IntentionsPre-Intervention Child Intentions toward healthy eating27.62 score on a scaleStandard Deviation 10.74
VideoChange in Behavioral Beliefs (Attitudes) and IntentionsPost-Intervention Child Intentions toward healthy eating31.46 score on a scaleStandard Deviation 11.1
VideoChange in Behavioral Beliefs (Attitudes) and IntentionsPre-Intervention Child attitudes toward healthy eating21.31 score on a scaleStandard Deviation 7.18
VideoChange in Behavioral Beliefs (Attitudes) and IntentionsPost-Intervention Child Healthy eating attitudes21.85 score on a scaleStandard Deviation 7.12
VideoChange in Behavioral Beliefs (Attitudes) and IntentionsPre-Intervention parent intentions toward healthy eating24.54 score on a scaleStandard Deviation 3.13
VideoChange in Behavioral Beliefs (Attitudes) and IntentionsPost-Intervention parent intentions toward healthy eating25 score on a scaleStandard Deviation 3.14
Virtual RealityChange in Behavioral Beliefs (Attitudes) and IntentionsPre-Intervention parent intentions toward healthy eating24.36 score on a scaleStandard Deviation 6.28
Virtual RealityChange in Behavioral Beliefs (Attitudes) and IntentionsPre-Intervention Child Intentions toward healthy eating25.14 score on a scaleStandard Deviation 9.45
Virtual RealityChange in Behavioral Beliefs (Attitudes) and IntentionsPost-Intervention Child Healthy eating attitudes21.71 score on a scaleStandard Deviation 5.01
Virtual RealityChange in Behavioral Beliefs (Attitudes) and IntentionsPost-Intervention Child Intentions toward healthy eating27 score on a scaleStandard Deviation 8.8
Virtual RealityChange in Behavioral Beliefs (Attitudes) and IntentionsPost-Intervention parent intentions toward healthy eating26.93 score on a scaleStandard Deviation 1.94
Virtual RealityChange in Behavioral Beliefs (Attitudes) and IntentionsPre-Intervention Child attitudes toward healthy eating19.36 score on a scaleStandard Deviation 4.13
Comparison: This analysis is for the outcome: Change in child attitudes toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child attitudes toward healthy eating from baseline to post-intervention does not differ between conditions.p-value: 0.78395% CI: [-4.39, 3.34]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in child intentions toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child intentions toward healthy eating from baseline to post-intervention does not differ between conditions.p-value: 0.32395% CI: [-6.05, 2.07]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in caregiver intentions toward helping their child engage in healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions from baseline to post-intervention does not differ between conditions.p-value: 0.27695% CI: [-1.79, 6.01]t-test, 2 sided
Primary

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.

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

Population: Data were reported by the caregivers only. Only one score is reported for each child-caregiver dyad. These measures were not collected from children.

ArmMeasureGroupValue (MEAN)Dispersion
VideoChange in Caregiver Readiness to Change Diet and Physical ActivityPre-intervention intend to help child change eating3.15 score on a scaleStandard Deviation 0.8
VideoChange in Caregiver Readiness to Change Diet and Physical ActivityTwo-week post-intervention intend to help child change eating3.31 score on a scaleStandard Deviation 0.86
VideoChange in Caregiver Readiness to Change Diet and Physical ActivityPre-intervention intend to help child change activity3.08 score on a scaleStandard Deviation 0.86
VideoChange in Caregiver Readiness to Change Diet and Physical ActivityTwo-week Post-intervention intend to help child change activity3.31 score on a scaleStandard Deviation 0.95
Virtual RealityChange in Caregiver Readiness to Change Diet and Physical ActivityTwo-week Post-intervention intend to help child change activity3.64 score on a scaleStandard Deviation 0.63
Virtual RealityChange in Caregiver Readiness to Change Diet and Physical ActivityPre-intervention intend to help child change eating3.43 score on a scaleStandard Deviation 0.51
Virtual RealityChange in Caregiver Readiness to Change Diet and Physical ActivityPre-intervention intend to help child change activity3.29 score on a scaleStandard Deviation 0.73
Virtual RealityChange in Caregiver Readiness to Change Diet and Physical ActivityTwo-week post-intervention intend to help child change eating3.86 score on a scaleStandard Deviation 0.36
Comparison: This analysis is for the outcome: Change in Caregiver Readiness to Change Child's Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in readiness for healthy eating does not differ between conditions.p-value: 0.36895% CI: [-0.342, 0.892]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in Caregiver Readiness for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions to help child improve physical activity from baseline to two-week follow up does not differ between conditions.p-value: 0.71495% CI: [-0.575, 0.827]t-test, 2 sided
Primary

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.

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

Population: Data were reported by the child only. These data were not collected from caregivers.

ArmMeasureGroupValue (MEAN)Dispersion
VideoChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Pre-intervention Physical Activity24.08 score on a scaleStandard Deviation 7.32
VideoChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Post-intervention Physical Activity26.23 score on a scaleStandard Deviation 9.37
VideoChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Pre-intervention healthy eating26.08 score on a scaleStandard Deviation 9.68
VideoChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Post-intervention healthy eating28.69 score on a scaleStandard Deviation 9.89
Virtual RealityChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Post-intervention healthy eating28.07 score on a scaleStandard Deviation 7.89
Virtual RealityChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Pre-intervention Physical Activity23.64 score on a scaleStandard Deviation 8.05
Virtual RealityChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Pre-intervention healthy eating26.64 score on a scaleStandard Deviation 6.87
Virtual RealityChange in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)Post-intervention Physical Activity26.93 score on a scaleStandard Deviation 7.73
Comparison: This analysis is for the outcome: Change in Self-Efficacy for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for physical activity does not differ between conditions.p-value: 0.59295% CI: [-3.16, 5.43]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in Self-Efficacy for Healthy Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for healthy eating does not differ between conditions.p-value: 0.45395% CI: [-4.39, 2.02]t-test, 2 sided
Secondary

Change in Child Diet

Parents reported on their child's eating behavior of the previous week with three different items asking parents to report the number of servings per week the child ate of fruits, vegetables, and fast foods.

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

Population: Data were reported by the caregivers, who reported for on the child's behavior. Only one score is reported for each child-caregiver dyad.

ArmMeasureGroupValue (MEAN)Dispersion
VideoChange in Child DietPre-intervention Weekly intake of fruits3.23 servings per weekStandard Deviation 1.42
VideoChange in Child DietPre-intervention Weekly intake of vegetables2.85 servings per weekStandard Deviation 0.9
VideoChange in Child DietPre-intervention Weekly intake of fast foods2 servings per weekStandard Deviation 0.58
VideoChange in Child DietTwo-week Post-intervention Weekly intake of fruits2.77 servings per weekStandard Deviation 1.3
VideoChange in Child DietTwo-week Post-intervention Weekly intake of vegetables2.92 servings per weekStandard Deviation 1.12
VideoChange in Child DietTwo-week Post-intervention Weekly intake of fast food1.85 servings per weekStandard Deviation 0.56
Virtual RealityChange in Child DietTwo-week Post-intervention Weekly intake of vegetables3.57 servings per weekStandard Deviation 0.94
Virtual RealityChange in Child DietPre-intervention Weekly intake of fruits3.50 servings per weekStandard Deviation 1.09
Virtual RealityChange in Child DietTwo-week Post-intervention Weekly intake of fruits3.29 servings per weekStandard Deviation 1.07
Virtual RealityChange in Child DietPre-intervention Weekly intake of vegetables3.5 servings per weekStandard Deviation 0.86
Virtual RealityChange in Child DietTwo-week Post-intervention Weekly intake of fast food1.79 servings per weekStandard Deviation 0.7
Virtual RealityChange in Child DietPre-intervention Weekly intake of fast foods2.14 servings per weekStandard Deviation 1.1
Comparison: This analysis is for the outcome: Change in child intake of fruits. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fruit servings per week from baseline to two-week follow up does not differ between conditions.p-value: 0.54795% CI: [-0.59, 1.08]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in child intake of vegetables. It is an independent samples t test. It is testing the null hypothesis that the mean change in child vegetable servings per week from baseline to two-week follow up does not differ between conditions.p-value: 0.9995% CI: [-0.87, 0.86]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in child intake of fast food. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fast food servings per week from baseline to two-week follow up does not differ between conditions.p-value: 0.52795% CI: [-0.86, 0.45]t-test, 2 sided
Secondary

Change in Child Eating Behavior

Parents reported on their child's eating behavior of the previous week with two different items asking parents to report the number of days per week the child ate breakfast and family dinner.

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

Population: Data were reported by the caregivers, who reported for on the child's behavior. Only one score is reported for each child-caregiver dyad.

ArmMeasureGroupValue (MEAN)Dispersion
VideoChange in Child Eating BehaviorPre-intervention family dinner4.54 days per weekStandard Deviation 2.11
VideoChange in Child Eating BehaviorPre-intervention intake of breakfast5.54 days per weekStandard Deviation 1.61
VideoChange in Child Eating BehaviorTwo-week Post-intervention Weekly intake of breakfast5.77 days per weekStandard Deviation 1.64
VideoChange in Child Eating BehaviorTwo-week Post-intervention Weekly intake of family dinner4.85 days per weekStandard Deviation 1.72
Virtual RealityChange in Child Eating BehaviorTwo-week Post-intervention Weekly intake of family dinner4.5 days per weekStandard Deviation 2.03
Virtual RealityChange in Child Eating BehaviorPre-intervention family dinner4.93 days per weekStandard Deviation 2.5
Virtual RealityChange in Child Eating BehaviorTwo-week Post-intervention Weekly intake of breakfast5.93 days per weekStandard Deviation 0.92
Virtual RealityChange in Child Eating BehaviorPre-intervention intake of breakfast5.86 days per weekStandard Deviation 1.66
Comparison: This analysis is for the outcome: Change in child weekly intake of breakfast. It is an independent samples t test. It is testing the null hypothesis that the mean change in child breakfast meals per week from baseline to two-week follow up does not differ between conditions.p-value: 0.77795% CI: [-1.33, 1.01]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in child intake of family dinners. It is an independent samples t test. It is testing the null hypothesis that the mean change in child family dinners per week from baseline to two-week follow up does not differ between conditions.p-value: 0.32995% CI: [-2.26, 0.79]t-test, 2 sided
Secondary

Change in Screen Time and Activity Behavior

Parents reported on their child's activity behavior of the previous week with two different items asking parents to report the average number of hours per day the child engaged in screen time and physical activity, on a scale from 1 to 5, with 1 = none; 2 = less than 1 hour per day; 3 = 1 to 2 hours per day; 4 = 3 to 4 hours per day; 5 = more than 4 hours per day.

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

Population: Data were reported by the caregivers, who reported for on the child's behavior. Only one score is reported for each child-caregiver dyad.

ArmMeasureGroupValue (MEAN)Dispersion
VideoChange in Screen Time and Activity BehaviorPre-intervention screen time4.31 units on a scaleStandard Deviation 0.88
VideoChange in Screen Time and Activity BehaviorPre-intervention active hours2.35 units on a scaleStandard Deviation 0.72
VideoChange in Screen Time and Activity BehaviorTwo-week Post-intervention screen time3.35 units on a scaleStandard Deviation 1.05
VideoChange in Screen Time and Activity BehaviorTwo-week Post-intervention active hours2.54 units on a scaleStandard Deviation 0.8
Virtual RealityChange in Screen Time and Activity BehaviorTwo-week Post-intervention active hours2.96 units on a scaleStandard Deviation 0.46
Virtual RealityChange in Screen Time and Activity BehaviorPre-intervention screen time4.11 units on a scaleStandard Deviation 1.02
Virtual RealityChange in Screen Time and Activity BehaviorTwo-week Post-intervention screen time3.61 units on a scaleStandard Deviation 1.2
Virtual RealityChange in Screen Time and Activity BehaviorPre-intervention active hours2.89 units on a scaleStandard Deviation 0.66
Comparison: This analysis is for the outcome: Change in child screentime. It is an independent samples t test. It is testing the null hypothesis that the mean change in child screentime per week from baseline to two-week follow up does not differ between conditions.p-value: 0.08695% CI: [-0.07, 0.99]t-test, 2 sided
Comparison: This analysis is for the outcome: Change in child active hours. It is an independent samples t test. It is testing the null hypothesis that the mean change in child active hours per week from baseline to two-week follow up does not differ between conditions.p-value: 0.6495% CI: [-0.64, 0.4]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026