NCT01888172

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 (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.1 years

First QC Date

June 24, 2013

Last Update Submit

September 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body weight, measured in kilograms

    3, 6, 9, and 12 months after randomizaiton

Secondary Outcomes (2)

  • Engagement with the electronic intervention system

    3, 6, 9, and 12 months after randomization

  • Blood pressure

    3, 6, 9, and 12 months after randomization

Study Arms (3)

Weight Watchers Online

EXPERIMENTAL
Behavioral: Weight Watchers Online Program

Weight Watchers Online + ActiveLink

EXPERIMENTAL
Behavioral: Weight Watchers Online ProgramDevice: Philips ActiveLink

Internet Delivered Eating and Activity Program

ACTIVE COMPARATOR
Behavioral: Eating and Activity Newsletter

Interventions

Access to the Weight Watchers Online program available via the Internet on personal computers, tablet computers, and smartphones.

Weight Watchers OnlineWeight Watchers Online + 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.

Weight Watchers Online + ActiveLink

General information on healthy eating and physical activity habits and the medical consequences of overweight/obesity and weight loss.

Internet Delivered Eating and Activity Program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miriam Hospital Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (1)

  • Thomas JG, Raynor HA, Bond DS, Luke AK, Cardoso CC, Foster GD, Wing RR. Weight loss in Weight Watchers Online with and without an activity tracking device compared to control: A randomized trial. Obesity (Silver Spring). 2017 Jun;25(6):1014-1021. doi: 10.1002/oby.21846. Epub 2017 Apr 24.

MeSH Terms

Conditions

OverweightObesity

Interventions

Eating

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 27, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations