Weight LossNCT04534088
A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
A study testing Standard Behavioral Weight Loss plus Non-Weight-Related VR app and Standard Behavioral Weight Loss plus Weight-Related VR app in people with Weight Loss, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
A pilot randomized trial was done to test the feasibility integrating virtual reality (VR) into standard behavioral weight loss treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Standard Behavioral Weight Loss plus Non-Weight-Related VR app and Standard Behavioral Weight Loss plus Weight-Related VR app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-pregnant Adults (age > 18 years) Overweight or obesity (BMI ≥ 25) Able to speak and read in English. Available on Thursday evenings Have an iPhone 6 or higher
Who cannot join
- Self-reported serious psychological problems or medical problems
Trial locations and contacts
1 site in 1 country.
About this study
A pilot randomized trial was done to test the feasibility integrating virtual reality (VR) into standard behavioral weight loss treatment.
Read the detailed description
Participants with overweight or obesity are randomly assigned to a 4-week Standard Behavioral Weight Loss plus Non-Weight-Related VR app (i.e., Control Group) or Standard Behavioral Weight Loss plus Weight-Related VR app (i.e., Intervention Group). The Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity.
- Conditions
- Weight Loss
- Being tested
- Standard Behavioral Weight Loss plus Non-Weight-Related VR app, Standard Behavioral Weight Loss plus Weight-Related VR app
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Behavioral Weight Loss plus Non-Weight-Related VR appBehavioural
Standard Behavioral Weight Loss Program
Standard Behavioral Weight Loss plus Weight-Related VR appBehavioural
Standard Behavioral Weight Loss plus Weight-Related VR app
| Study group | Role | What they receive |
|---|---|---|
| Standard Behavioral Weight Loss plus Non-Weight-Related VR app | Active comparator | The VR tool was an attention control and was not weight related. Receives: Behavioral: Standard Behavioral Weight Loss plus Non-Weight-Related VR app |
| Standard Behavioral Weight Loss plus Weight-Related VR app | Experimental | The Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity. Receives: Behavioral: Standard Behavioral Weight Loss plus Weight-Related VR app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Satisfaction
Participant satisfaction ratings of virtual reality scenarios on a scale where 1 = very dissatisfied to 4 = very satisfied
Measured: 4 weeks
Secondary outcomes (1)
Proportion of participants retained
Number of participants who complete the final assessment divided by the number of participants enrolled at baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Phelan, California Polytechnic State University-San Luis Obispo
- Investigators
- Suzanne Phelan, PhD, Principal investigator, Cal Poly Dept. KPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534088
- Sponsor's protocol ID
- VH-CP
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phelan S, Peruvemba S, Levinson D, Stulberg N, Lacy A, Legato M, Werner JP. Feasibility of a virtual reality-based approach to improve behavioral weight management outcomes. Pilot Feasibility Stud. 2021 Jun 22;7(1):129. doi: 10.1186/s40814-021-00865-5.
PubMed 34158129
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual-reality Based Approach to Improve Behavioral Weight Management Outcomes
- ClinicalTrials.gov ID
- NCT04534088
- Acronym / sponsor ID
- VH-CP
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot randomized trial was done to test the feasibility integrating virtual reality (VR) into standard behavioral weight loss treatment.
Detailed description
Participants with overweight or obesity are randomly assigned to a 4-week Standard Behavioral Weight Loss plus Non-Weight-Related VR app (i.e., Control Group) or Standard Behavioral Weight Loss plus Weight-Related VR app (i.e., Intervention Group). The Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Behavioral Weight Loss plus Non-Weight-Related VR app | Active comparator | Behavioral: Standard Behavioral Weight Loss plus Non-Weight-Related VR appThe VR tool was an attention control and was not weight related. |
| Standard Behavioral Weight Loss plus Weight-Related VR app | Experimental | Behavioral: Standard Behavioral Weight Loss plus Weight-Related VR appThe Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-pregnant Adults (age > 18 years) Overweight or obesity (BMI ≥ 25) Able to speak and read in English. Available on Thursday evenings Have an iPhone 6 or higher
Key exclusion criteria (1 listed)
- Self-reported serious psychological problems or medical problems
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 |
|---|---|---|
| Standard Behavioral Weight Loss plus Non-Weight-Related VR appStandard Behavioral Weight Loss Program | Behavioural | Standard Behavioral Weight Loss plus Non-Weight-Related VR app |
| Standard Behavioral Weight Loss plus Weight-Related VR appStandard Behavioral Weight Loss plus Weight-Related VR app | Behavioural | Standard Behavioral Weight Loss plus Weight-Related VR app |
Primary outcome
Intervention Satisfaction
Time frame: 4 weeks
Participant satisfaction ratings of virtual reality scenarios on a scale where 1 = very dissatisfied to 4 = very satisfied
1 secondary outcome
Proportion of participants retained
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Derived from this study: PubMed 34158129Phelan S, Peruvemba S, Levinson D, Stulberg N, Lacy A, Legato M, Werner JP. Feasibility of a virtual reality-based approach to improve behavioral weight management outcomes. Pilot Feasibility Stud. 2021 Jun 22;7(1):129. doi: 10.1186/s40814-021-00865-5.
- Individual participant dataSharing planned: No
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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.
Suzanne Phelan, PhD principal investigator
Cal Poly Dept. KPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Behavioral Weight Loss plus Non-Weight-Related VR app and Standard Behavioral Weight Loss plus Weight-Related VR app in people with Weight Loss, run by California Polytechnic State University-San Luis Obispo 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 1 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 24 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intervention Satisfaction (time frame: 4 weeks). 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 NCT04534088, 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 24 Sep 2020.