- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417220
Weight Watchers Online 2015 (WWO 2015)
March 28, 2016 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 revised for 2015 (WWO2015) and WWO2015 plus the provision of an electronic scale and weekly email feedback on weight loss (WWO2015 Enhanced), over a 6-month period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
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
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Weight Control and Diabetes Resarch 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:
- Age 18-70 years
- Body mass index (BMI) between 27 and 40 kg/m2
- Both genders will be recruited; At least 10% of participants will be men. Enrollment of women will be capped at n = 324 (90%) to meet this goal.
- All ethnic groups will be recruited, with a goal of recruiting 10% minorities
- 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 Questionnaire1
- 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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Weight Watchers Online 2015
|
Access to the Weight Watchers Online 2015 program available via the Internet on personal computers, tablet computers, and/or smartphones already owned by participants.
|
|
Experimental: Weight Watchers Online 2015 Enhanced
|
Access to the Weight Watchers Online 2015 program available via the Internet on personal computers, tablet computers, and/or smartphones already owned by participants.
Provision of an electronic scale that automatically transmits body weights to the Weight Watchers Online 2015 program, which generates a weekly feedback message on weight loss progress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in body weight, measured in kilograms
Time Frame: 3 and 6 months after randomization
|
3 and 6 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Engagement with the electronic intervention system, measured by number of body weights, foods, and physical activity bouts recorded per week
Time Frame: 3 and 6 months after randomization
|
3 and 6 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
April 8, 2015
First Submitted That Met QC Criteria
April 10, 2015
First Posted (Estimate)
April 15, 2015
Study Record Updates
Last Update Posted (Estimate)
March 29, 2016
Last Update Submitted That Met QC Criteria
March 28, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WeightWatchersOnline2015
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.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Weight Watchers Online 2015 Program
-
The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalCompleted
-
The Miriam HospitalVirtually Better, Inc.UnknownObesity | OverweightUnited States
-
University of California, San FranciscoWithdrawnMorbid ObesityUnited States
-
Indiana UniversityIndiana Clinical and Translational Sciences Institute; Weight Watchers International and other collaboratorsCompletedObesity | Prediabetes | Gestational Diabetes MellitusUnited States
-
Medical University of South CarolinaWeight Watchers InternationalCompletedObesity | Overweight | Type 2 DiabetesUnited States
-
The Miriam HospitalCompleted
-
University of PittsburghCompleted
-
University of ConnecticutWeight Watchers InternationalCompletedOverweight and Obesity
-
University of PennsylvaniaWW International IncCompleted
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed