- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836132
Experience Success: Virtual Reality Skills Training to Enhance e-Weight Loss
July 18, 2016 updated by: The Miriam Hospital
The aim of this Phase II Small Business Technology Transfer grant is to complete development of a virtual reality intervention to augment and improve commercial Internet-delivered behavioral weight loss treatments, and to test it in a randomized controlled trial.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Overweight and obesity are major health problems, affecting over two-thirds of US adults.
Commercially available Internet-based weight loss programs are currently used by millions of overweight/obese individuals in the U.S, but weight losses are often poor, likely because these products on the whole do not incorporate empirically validated behavioral weight loss strategies that have been researched for over 40 years.
Similarly, the weight losses obtained via research-based online weight loss programs are about half the size of those obtained via in-person treatment, likely because of the lack of (1) "hands-on" training in behavioral weight control strategies, and (2) support and guidance from group leaders and peers, both of which are hallmarks of traditional in-person treatment.
The goal of this application is to improve commercial Internet -delivered behavioral obesity treatments by developing a virtual reality (VR) system that can be integrated into existing Internet weight control programs, such as Weight Watchers Online.
The VR system will allow users to experience learning, implementing, and mastering behavioral weight control strategies in controlled virtual settings.
The VR system will: (a) increase awareness of barriers to weight control behaviors, (b) teach skills to cope with these barriers, (c) build confidence using these skills, and (d) increase commitment to using these skills in real-world situations.
The design of the VR System is based on Social Cognitive Theory, which states that health behaviors are learned by observing and imitating peers and role models, and by receiving social reinforcement.
A randomized controlled trial (RCT) will be conducted with N = 125 participants to test the efficacy of 4 scenarios for improving weight losses obtained in a popular paid commercial weight loss program (Weight Watchers Online) over 6 months.
Study Type
Interventional
Enrollment (Anticipated)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Recruiting
- The Miriam Hospital Weight Control and Diabetes Research Center
-
Principal Investigator:
- Graham Thomas, PhD
-
Contact:
- Marie Kearns, MS
- Phone Number: 401-793-8253
- Email: mkearns@lifespan.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- body mass index (BMI) 25-45 kg/m^2
- English speaking and literate
- able to walk 2 blocks unassisted without stopping
- access to a computer and the Internet
Exclusion Criteria:
- report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity
- report of a condition that in the judgment of the Principal Investigator would render the participant potentially unlikely to be able to follow the study protocol for 6 months, including terminal illness, substance abuse, eating disorder, dementia, or other significant uncontrolled psychiatric problem
- currently pregnant, within 6-months postpartum, or intend to become pregnant within 6 months
- plan to move out of the local geographic area within 6 months
- previous participation in a weight loss study at the Weight Control and Diabetes Research Center of Brown University and The Miriam Hospital within the last 2 years
- current participation in another behavioral weight control program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Weight Watchers Online
Participants will receive 6 months of no-cost access to the Weight Watchers Online platform.
|
|
|
Experimental: Weight Watchers Online + Experience Success
Participants will receive 6 months of no-cost access to the Weight Watchers Online platform.
They will also receive 6 months of no-cost access to the Experience Success online platform, with 4 virtual reality scenarios for training in behavioral weight loss skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight loss
Time Frame: 3 months after beginning treatment
|
3 months after beginning treatment
|
|
Weight loss
Time Frame: 6 months after beginning treatment
|
6 months after beginning treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
July 14, 2016
First Submitted That Met QC Criteria
July 14, 2016
First Posted (Estimate)
July 18, 2016
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
July 18, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R42DK103537 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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