Recruiting

Virtual Reality

Sponsor:

The Miriam Hospital

Code:

NCT02836132

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Weight Watchers Online

Experience Success Virtual Reality Platform

Study Details

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.

Conditions

Overweight

Obesity

Study ID

NCT02836132

Start date

Jul, 2016

Status verified date

Jul, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Weight Watchers Online

Experience Success Virtual Reality Platform

Primary outcome measure

  • Weight loss [ Time Frame: 3 months after beginning treatment ]
  • Weight loss [ Time Frame: 6 months after beginning treatment ]

Central Contacts and Locations

Central contacts

Marie Kearns, MS

4017938253mkearns@lifespan.org

Locations

The Miriam Hospital Weight Control and Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Marie Kearns, MS

401-793-8253mkearns@lifespan.org

Principal Investigator:

Graham Thomas, PHD

More Information

Sponsor

The Miriam Hospital

Last update posted

Jul 19, 2016

Last verified

Jul, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2016-07-19.