NCT02836132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 14, 2016

Last Update Submit

July 18, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Weight loss

    3 months after beginning treatment

  • Weight loss

    6 months after beginning treatment

Study Arms (2)

Weight Watchers Online

ACTIVE COMPARATOR

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

Behavioral: Weight Watchers Online

Weight Watchers Online + Experience Success

EXPERIMENTAL

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 OnlineBehavioral: Experience Success Virtual Reality Platform

Interventions

Weight Watchers OnlineWeight Watchers Online + Experience Success
Weight Watchers Online + Experience Success

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Marie Kearns, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 18, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations