Weight Watchers Online (WWO)

September 21, 2015 updated by: John Graham Thomas, The Miriam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Miriam Hospital Weight Control & Diabetes Research Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • University of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Weight Watchers Online
Behavioral: Weight Watchers Online Program
Access to the Weight Watchers Online program available via the Internet on personal computers, tablet computers, and smartphones.
EXPERIMENTAL: Weight Watchers Online + ActiveLink
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.
ACTIVE_COMPARATOR: Internet Delivered Eating and Activity Program
Behavioral: Eating and Activity Newsletter
General information on healthy eating and physical activity habits and the medical consequences of overweight/obesity and weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight, measured in kilograms
Time Frame: 3, 6, 9, and 12 months after randomizaiton
3, 6, 9, and 12 months after randomizaiton

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3, 6, 9, and 12 months after randomization
Blood pressure
Time Frame: 3, 6, 9, and 12 months after randomization
3, 6, 9, and 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

University of Tennessee
Weight Watchers International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (ESTIMATE)

June 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WeightWatchersOnline

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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