Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Weight Watchers Online (WWO)

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: NCT01888172
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : September 23, 2015
Sponsor:
Collaborators:
Weight Watchers International
University of Tennessee
Information provided by (Responsible Party):
John Graham Thomas, The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Change in body weight, measured in kilograms [ Time Frame: 3, 6, 9, and 12 months after randomizaiton ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Engagement with the electronic intervention system [ Time Frame: 3, 6, 9, and 12 months after randomization ]
    The frequency with with participants interact with the Weight Watchers Online and control group websites.
  • Blood pressure [ Time Frame: 3, 6, 9, and 12 months after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight Watchers Online
Official Title  ICMJE Weight Watchers Online
Brief Summary The purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • Behavioral: Weight Watchers Online Program
    Access to the Weight Watchers Online program available via the Internet on personal computers, tablet computers, and smartphones.
  • Device: Philips ActiveLink
    Provision of a key-chain sized physical activity monitor that interfaces with the Weight Watchers website to promote exercise and give feedback on progress towards exercise goals.
  • Behavioral: Eating and Activity Newsletter
    General information on healthy eating and physical activity habits and the medical consequences of overweight/obesity and weight loss.
Study Arms  ICMJE
  • Experimental: Weight Watchers Online
    Intervention: Behavioral: Weight Watchers Online Program
  • Experimental: Weight Watchers Online + ActiveLink
    Interventions:
    • Behavioral: Weight Watchers Online Program
    • Device: Philips ActiveLink
  • Active Comparator: Internet Delivered Eating and Activity Program
    Intervention: Behavioral: Eating and Activity Newsletter
Publications * Thomas JG, Raynor HA, Bond DS, Luke AK, Cardoso CC, Foster GD, Wing RR. Weight loss in Weight Watchers Online with and without an activity tracking device compared to control: A randomized trial. Obesity (Silver Spring). 2017 Jun;25(6):1014-1021. doi: 10.1002/oby.21846. Epub 2017 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 6, 2015)
270
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
360
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) between 27 and 40 kg/m2
  • All ethnic groups will be recruited
  • English speaking
  • Have access to the Internet via a computer, and basic computer skills

Exclusion Criteria:

  • Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
  • Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
  • Are planning to move outside of the state within the next 12 months
  • Report any cognitive or physical limitations that preclude use of a personal computer
  • Have participated in a study conducted by the WCDRC or UT in the past 2 years
  • Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program
  • Weight loss of ≥ 5% of initial body weight in the last 6 months
  • History of clinically diagnosed eating disorder excluding Binge Eating Disorder.
  • Previous surgical procedure for weight loss
  • Currently taking weight loss medication
  • Treatment of cancer within the last 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888172
Other Study ID Numbers  ICMJE WeightWatchersOnline
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Graham Thomas, The Miriam Hospital
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE
  • Weight Watchers International
  • University of Tennessee
Investigators  ICMJE Not Provided
PRS Account The Miriam Hospital
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP