Weight Watchers Online 2015

Obesity Clinical Trial

— WWO 2015  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417220
• Other study ID #: WeightWatchersOnline2015
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: March 28, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Behavioral:
• Weight Watchers Online 2015 Program
Access to the Weight Watchers Online 2015 program available via the Internet on personal computers, tablet computers, and/or smartphones already owned by participants.

Other:
• Electronic Scale with Feedback
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.

Locations

Country	Name	City	State
United States	University of Tennessee	Knoxville	Tennessee
United States	Weight Control and Diabetes Resarch Center	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	University of Tennessee, Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight, measured in kilograms		3 and 6 months after randomization	No
Secondary	Engagement with the electronic intervention system, measured by number of body weights, foods, and physical activity bouts recorded per week		3 and 6 months after randomization	No