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Weight Watchers Online 2015 (WWO 2015)

Primary Purpose

Obesity, Overweight, Body Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Watchers Online 2015 Program
Electronic Scale with Feedback
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weight Control and Diabetes Resarch Center
  • University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weight Watchers Online 2015

Weight Watchers Online 2015 Enhanced

Arm Description

Outcomes

Primary Outcome Measures

Change in body weight, measured in kilograms

Secondary Outcome Measures

Engagement with the electronic intervention system, measured by number of body weights, foods, and physical activity bouts recorded per week

Full Information

First Posted
April 8, 2015
Last Updated
March 28, 2016
Sponsor
The Miriam Hospital
Collaborators
Weight Watchers International, University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT02417220
Brief Title
Weight Watchers Online 2015
Acronym
WWO 2015
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
Weight Watchers International, University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Body Weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Watchers Online 2015
Arm Type
Active Comparator
Arm Title
Weight Watchers Online 2015 Enhanced
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Weight Watchers Online 2015 Program
Intervention Description
Access to the Weight Watchers Online 2015 program available via the Internet on personal computers, tablet computers, and/or smartphones already owned by participants.
Intervention Type
Other
Intervention Name(s)
Electronic Scale with Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight, measured in kilograms
Time Frame
3 and 6 months after randomization
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Weight Control and Diabetes Resarch Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

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Weight Watchers Online 2015

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