Weight LossNCT01841372
A Virtual Reality Intervention to Improve Weight Maintenance
A study testing Second Life and Group Phone Conference Call in people with Weight Loss, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if use of a virtual reality platform, Second Life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Second Life and Group Phone Conference Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 15 Mar 2020
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with a BMI of 25 to 39.9 kg/m2
- Able to obtain clearance for participation from their primary care physician (PCP)
- Have access to a computer with internet that meets Second Life system requirements
Who cannot join
- Report participating in a research project involving weight loss or PA in the previous 6 months
- Report a regular exercise or PA program
- Not weight stable (+/-2.27 kg) for 3 months prior to intake
- Unwilling to be randomized to phone or 2L clinics subsequent to weight loss
- Report being pregnant during the previous 6 months, lactating, or planned pregnancy in the following 18 months
- Report serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)
Show all 10Show fewer
- Report eating disorders as determined by the Eating Attitudes Test using a score of 20 or greater
- Report current treatment for psychological issues, or taking psychotropic medications
- Report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, macrobiotic, etc.
- Do not have access to grocery shopping and meal preparation (i.e. Military, college cafeteria plan, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance
The purpose of this study is to determine if use of a virtual reality platform, Second Life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals.
Read the detailed description
This study has two main parts. During the first 6 months (-6 to 0 months)potential subjects will be on a diet developed by researchers at the University of Kansas Medical Center (KUMC). Subsequent to 6 months, participants who lost 5% weight will begin the weight maintenance phase of the study (0-12 months). Thus the total duration of the study is 18 months.
Approximately 68% of U.S. adults are classified as overweight or obese (BMI >25). Behaviorally based weight loss programs, typically delivered by face-to-face clinics, produce clinically significant reductions in body weight over 3-6 months. However, approximately 50% of those who lose weight regain more than 45-75% of the weight lost within 12-30 months. Face-to-face clinics present many barriers and burdens to individuals including scheduling and logistical and financial burdens.
Virtual Reality (VR) environments allow participants to create virtual representations of themselves called "avatars". An existing VR called "Second Life" will be used for participants randomized to VR. Participants avatars attend group meetings and use headsets for voice communication to interact with each other.
Those not randomized to VR will participate in traditional face-to-face group weight loss intervention. The study will examine many different factors to determine if those participants in the Second Life group experience improved weight maintenance.
- Conditions
- Weight Loss
- Being tested
- Second Life, Group Phone Conference Call
- Keywords
- Obesity, Overweight, Weight Maintenance
- Medical subject headings
- Weight Loss, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second LifeOther
Second Life is an online virtual reality environment.
Group Phone Conference CallBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group Phone Conference Call | Active comparator | Group phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months). Receives: Behavioral: Group Phone Conference Call |
| Second Life (2L) | Experimental | 2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months Receives: Other: Second Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Weight Change
Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.
Measured: Change from month 0 (after 6 mo weight loss) to Month 12
Secondary outcomes (4)
Total Attendance at Meetings
Number of times each individual attended group meeting during the course of the weight maintenance phase.
Measured: Month 0 to12 Months
Assessment of Self-Efficacy for Weight Loss
Weight loss self-efficacy will be assessed using the Weight Efficacy Lifestyle Questionnaire. This scale assess overeating in tempting situations. Participants rate their level of confidence on a 10-point Likert-scale with higher values indicating greater confidence to resist overeating.
Measured: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Physical Activity (PA)
Physical activity self-efficacy will be assessed using the 5-item exercise self-efficacy scale. Participants rate their confidence level (1 = not confident at all to 7 = very confident) to engage in PA in a number of different situations including making time for exercise, resisting lapse, etc.
Measured: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Problem Solving Skills
Problem-solving abilities will be assessed using the Social Problem Solving Inventory-Revised, short form (SPSI-R:S). The SPSI-R:S is a 25-item instrument with five component scales to assess problem-solving styles and solution generation.
Measured: Change from Month 0 to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startSep 2013
- Primary completion1 Mar 2020
- Study completion15 Mar 2020
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Donnelly, University of Kansas Medical Center
- Investigators
- Joseph Donnelly, Ed.D., Principal investigator, University of Kansas Medical CenterDebra Sullivan, PhD, RD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841372
- Sponsor's protocol ID
- 13610
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sullivan DK, Goetz JR, Gibson CA, Mayo MS, Washburn RA, Lee Y, Ptomey LT, Donnelly JE. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial. Contemp Clin Trials. 2016 Jan;46:77-84. doi: 10.1016/j.cct.2015.11.019. Epub 2015 Nov 23.
PubMed 26616535
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality Intervention (Second Life) to Improve Weight Maintenance
- ClinicalTrials.gov ID
- NCT01841372
- Acronym / sponsor ID
- 13610
- Conditions
- Weight Loss
- Keywords
- Obesity, Overweight, Weight Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 26 Apr 2013 (estimated)
- 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.
The purpose of this study is to determine if use of a virtual reality platform, Second Life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals.
Detailed description
This study has two main parts. During the first 6 months (-6 to 0 months)potential subjects will be on a diet developed by researchers at the University of Kansas Medical Center (KUMC). Subsequent to 6 months, participants who lost 5% weight will begin the weight maintenance phase of the study (0-12 months). Thus the total duration of the study is 18 months.
Approximately 68% of U.S. adults are classified as overweight or obese (BMI >25). Behaviorally based weight loss programs, typically delivered by face-to-face clinics, produce clinically significant reductions in body weight over 3-6 months. However, approximately 50% of those who lose weight regain more than 45-75% of the weight lost within 12-30 months. Face-to-face clinics present many barriers and burdens to individuals including scheduling and logistical and financial burdens.
Virtual Reality (VR) environments allow participants to create virtual representations of themselves called "avatars". An existing VR called "Second Life" will be used for participants randomized to VR. Participants avatars attend group meetings and use headsets for voice communication to interact with each other.
Those not randomized to VR will participate in traditional face-to-face group weight loss intervention. The study will examine many different factors to determine if those participants in the Second Life group experience improved weight maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Phone Conference Call | Active comparator | Behavioral: Group Phone Conference CallGroup phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months). |
| Second Life (2L) | Experimental | Other: Second Life2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women with a BMI of 25 to 39.9 kg/m2
- Able to obtain clearance for participation from their primary care physician (PCP)
- Have access to a computer with internet that meets Second Life system requirements
Key exclusion criteria (10 listed)
- Report participating in a research project involving weight loss or PA in the previous 6 months
- Report a regular exercise or PA program
- Not weight stable (+/-2.27 kg) for 3 months prior to intake
- Unwilling to be randomized to phone or 2L clinics subsequent to weight loss
- Report being pregnant during the previous 6 months, lactating, or planned pregnancy in the following 18 months
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 |
|---|---|---|
| Second LifeSecond Life is an online virtual reality environment. | Other | Second Life (2L) |
| Group Phone Conference Call | Behavioural | Group Phone Conference Call |
Primary outcome
Difference in Weight Change
Time frame: Change from month 0 (after 6 mo weight loss) to Month 12
Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.
4 secondary outcomes
Total Attendance at Meetings
Time frame: Month 0 to12 Months
Assessment of Self-Efficacy for Weight Loss
Time frame: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Physical Activity (PA)
Time frame: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Problem Solving Skills
Time frame: Change from Month 0 to 12 Months
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 25 Mar 2020.
- Derived from this study: PubMed 26616535Sullivan DK, Goetz JR, Gibson CA, Mayo MS, Washburn RA, Lee Y, Ptomey LT, Donnelly JE. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial. Contemp Clin Trials. 2016 Jan;46:77-84. doi: 10.1016/j.cct.2015.11.019. Epub 2015 Nov 23.
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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.
Joseph Donnelly, Ed.D. principal investigator
University of Kansas Medical Center
Debra Sullivan, PhD, RD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second Life and Group Phone Conference Call in people with Weight Loss, run by University of Kansas Medical Center 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 3 inclusion and 10 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 25 Mar 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?
Difference in Weight Change (time frame: Change from month 0 (after 6 mo weight loss) to Month 12). 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 NCT01841372, 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 25 Mar 2020.