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

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Watchers Online
Experience Success Virtual Reality Platform
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Miriam Hospital Weight Control and Diabetes Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weight Watchers Online

Weight Watchers Online + Experience Success

Arm Description

Participants will receive 6 months of no-cost access to the Weight Watchers Online platform.

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.

Outcomes

Primary Outcome Measures

Weight loss
Weight loss

Secondary Outcome Measures

Full Information

First Posted
July 14, 2016
Last Updated
July 18, 2016
Sponsor
The Miriam Hospital
Collaborators
Virtually Better, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02836132
Brief Title
Experience Success: Virtual Reality Skills Training to Enhance e-Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
Virtually Better, Inc.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight Watchers Online
Arm Type
Active Comparator
Arm Description
Participants will receive 6 months of no-cost access to the Weight Watchers Online platform.
Arm Title
Weight Watchers Online + Experience Success
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Watchers Online
Intervention Type
Behavioral
Intervention Name(s)
Experience Success Virtual Reality Platform
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
3 months after beginning treatment
Title
Weight loss
Time Frame
6 months after beginning treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Kearns, MS
Phone
4017938253
Email
mkearns@lifespan.org
Facility Information:
Facility Name
The Miriam Hospital Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Kearns, MS
Phone
401-793-8253
Email
mkearns@lifespan.org
First Name & Middle Initial & Last Name & Degree
Graham Thomas, PHD

12. IPD Sharing Statement

Learn more about this trial

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

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