Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Experience Success: Virtual Reality Skills Training to Enhance e-Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836132
Recruitment Status : Unknown
Verified July 2016 by The Miriam Hospital.
Recruitment status was:  Recruiting
First Posted : July 18, 2016
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
Virtually Better, Inc.
Information provided by (Responsible Party):
The Miriam Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Weight Watchers Online Behavioral: Experience Success Virtual Reality Platform Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Weight Watchers Online
Participants will receive 6 months of no-cost access to the Weight Watchers Online platform.
Behavioral: Weight Watchers Online
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.
Behavioral: Weight Watchers Online
Behavioral: Experience Success Virtual Reality Platform



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 3 months after beginning treatment ]
  2. Weight loss [ Time Frame: 6 months after beginning treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836132


Contacts
Layout table for location contacts
Contact: Marie Kearns, MS 4017938253 mkearns@lifespan.org

Locations
Layout table for location information
United States, Rhode Island
The Miriam Hospital Weight Control and Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Marie Kearns, MS    401-793-8253    mkearns@lifespan.org   
Principal Investigator: Graham Thomas, PHD         
Sponsors and Collaborators
The Miriam Hospital
Virtually Better, Inc.
Layout table for additonal information
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02836132    
Other Study ID Numbers: R42DK103537 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Signs and Symptoms