NCT01841372

Brief Summary

The purpose of this study is to determine if use of a virtual reality platform, Second Life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

6.5 years

First QC Date

April 23, 2013

Last Update Submit

March 23, 2020

Conditions

Weight Loss

Keywords

ObesityOverweightWeight Maintenance

Outcome Measures

Primary Outcomes (1)

  • Difference in Weight Change

    Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.

    Change from month 0 (after 6 mo weight loss) to Month 12

Secondary Outcomes (4)

  • Total Attendance at Meetings

    Month 0 to12 Months

  • Assessment of Self-Efficacy for Weight Loss

    Change from Month 0 to 12 Months

  • Assessment of Self-Efficacy for Physical Activity (PA)

    Change from Month 0 to 12 Months

  • Assessment of Self-Efficacy for Problem Solving Skills

    Change from Month 0 to 12 Months

Study Arms (2)

Group Phone Conference Call

ACTIVE COMPARATOR

Group phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months).

Behavioral: Group Phone Conference Call

Second Life (2L)

EXPERIMENTAL

2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months

Other: Second Life

Interventions

Second LifeOTHER

Second Life is an online virtual reality environment.

Second Life (2L)
Group Phone Conference CallBEHAVIORAL
Group Phone Conference Call

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women with a BMI of 25 to 39.9 kg/m2
  • Able to obtain clearance for participation from their primary care physician (PCP)
  • Have access to a computer with internet that meets Second Life system requirements

You may not qualify if:

  • Report participating in a research project involving weight loss or PA in the previous 6 months
  • Report a regular exercise or PA program
  • Not weight stable (+/-2.27 kg) for 3 months prior to intake
  • Unwilling to be randomized to phone or 2L clinics subsequent to weight loss
  • Report being pregnant during the previous 6 months, lactating, or planned pregnancy in the following 18 months
  • Report serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)
  • Report eating disorders as determined by the Eating Attitudes Test using a score of 20 or greater
  • Report current treatment for psychological issues, or taking psychotropic medications
  • Report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, macrobiotic, etc.
  • Do not have access to grocery shopping and meal preparation (i.e. Military, college cafeteria plan, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Sullivan DK, Goetz JR, Gibson CA, Mayo MS, Washburn RA, Lee Y, Ptomey LT, Donnelly JE. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial. Contemp Clin Trials. 2016 Jan;46:77-84. doi: 10.1016/j.cct.2015.11.019. Epub 2015 Nov 23.

    PMID: 26616535DERIVED

MeSH Terms

Conditions

Weight LossObesityOverweight

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Joseph Donnelly, Ed.D.

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

  • Debra Sullivan, PhD, RD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 26, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2020

Study Completion

March 15, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

US(1)