NCT02417220

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

April 8, 2015

Last Update Submit

March 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body weight, measured in kilograms

    3 and 6 months after randomization

Secondary Outcomes (1)

  • 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

Study Arms (2)

Weight Watchers Online 2015

ACTIVE COMPARATOR
Behavioral: Weight Watchers Online 2015 Program

Weight Watchers Online 2015 Enhanced

EXPERIMENTAL
Behavioral: Weight Watchers Online 2015 ProgramOther: Electronic Scale with Feedback

Interventions

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

Weight Watchers Online 2015Weight Watchers Online 2015 Enhanced

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.

Weight Watchers Online 2015 Enhanced

Eligibility Criteria

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

You may qualify if:

  • 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

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Location

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

ObesityOverweightBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 15, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations