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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01888172
Other study ID # WeightWatchersOnline
Secondary ID
Status Completed
Phase N/A
First received June 24, 2013
Last updated September 21, 2015
Start date May 2013
Est. completion date June 2015

Study information

Verified date September 2015
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority
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 (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Tennessee Knoxville Tennessee
United States Miriam Hospital Weight Control & Diabetes Research 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, 6, 9, and 12 months after randomizaiton
Secondary Engagement with the electronic intervention system The frequency with with participants interact with the Weight Watchers Online and control group websites. 3, 6, 9, and 12 months after randomization
Secondary Blood pressure 3, 6, 9, and 12 months after randomization
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