Childhood ObesityNCT04845568
Testing Digital Technologies to Help Families Build Healthy Habits
A study testing Virtual Reality Experience in people with Childhood Obesity, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Virtual Reality Experience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2021to 7 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Virtual Reality Experience
- Keywords
- Virtual Reality, Obesity, Childhood Obesity
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ExperienceBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Reality Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At baseline and after the 10-minute, single-session, in-person intervention
Secondary outcomes (3)
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.
Measured: Immediately pre intervention/control and at 2 week follow-up
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.
Measured: Immediately pre intervention/control and at 2 week follow-up
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.
Measured: Immediately pre intervention/control and at 2 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start17 Apr 2021
- Primary completion7 May 2022
- Study completion7 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen E Fitzsimmons-Craft, PhD, Principal investigator, Washington University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845568
- Sponsor's protocol ID
- 202004074
- Status last verified
- Sep 2024
- First submitted
- 3 Mar 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consent to share data is collected and available upon reasonable request after the publication of main outcomes.
Publications
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.
PubMed 39534453
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Digital Technologies to Help Families Build Healthy Habits
- ClinicalTrials.gov ID
- NCT04845568
- Acronym / sponsor ID
- 202004074
- Conditions
- Childhood Obesity
- Keywords
- Virtual Reality, Obesity, Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 17 Apr 2021 (actual)
- Primary completion
- 7 May 2022 (actual)
- Study completion
- 7 May 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Virtual Reality ExperienceThis is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality ExperienceThe 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." | Behavioural | Virtual Reality |
Primary outcome
Acceptability as Measured by the System Usability Scale
Time frame: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
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."
Acceptability as Measured by the Usefulness, Satisfaction and Ease of Use Questionnaire
Time frame: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
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.
Acceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)
Time frame: Assessed immediately after the 10-minute, single-session, in-person virtual reality intervention
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.
Acceptability as Measured by Child Interview Questions
Time frame: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention
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.
Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA)
Time frame: Assessed at baseline (before the intervention) and immediately after the 10-minute, single-session, in-person virtual reality or video intervention
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.
Change in Caregiver Readiness to Change Diet and Physical Activity
Time frame: Items are assessed immediately pre intervention and at 2-weeks after intervention
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.
Change in Behavioral Beliefs (Attitudes) and Intentions
Time frame: At baseline and after the 10-minute, single-session, in-person intervention
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
3 secondary outcomes
Change in Child Diet
Time frame: Immediately pre intervention/control and at 2 week follow-up
Change in Child Eating Behavior
Time frame: Immediately pre intervention/control and at 2 week follow-up
Change in Screen Time and Activity Behavior
Time frame: Immediately pre intervention/control and at 2 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39534453Fowler 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.
- Individual participant dataSharing planned: Yes. Consent to share data is collected and available upon reasonable request after the publication of main outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen E Fitzsimmons-Craft, PhD principal investigator
Washington University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Experience in people with Childhood Obesity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as Measured by the System Usability Scale (time frame: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04845568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.