NCT00827593

Brief Summary

The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

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

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

January 22, 2009

Last Update Submit

April 12, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight loss

    3, 6, 12 months

Secondary Outcomes (1)

  • cost-effectiveness

    12 months

Study Arms (3)

Standard behavioral weight loss

ACTIVE COMPARATOR

University-based behavioral weight loss treatment

Behavioral: Standard behavioral weight loss treatment

Weight Watchers

ACTIVE COMPARATOR

Weight Watchers program

Behavioral: Weight Watchers

Combined Treatment

ACTIVE COMPARATOR

University-based behavioral weight loss treatment followed by Weight Watchers

Behavioral: Combined Treatment

Interventions

Participants will receive 12 months of university-based behavioral weight loss treatment

Standard behavioral weight loss
Weight WatchersBEHAVIORAL

Participants will receive 12 months of Weight Watchers

Weight Watchers

Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers

Combined Treatment

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30-65 years
  • BMI between 27-50 kg/m2
  • Written approval/consent from primary health care provider

You may not qualify if:

  • Unable to walk 2 blocks without stopping.
  • Currently participating in a weight loss program or taking weight loss medication.
  • Participated in a weight loss program in the last year
  • Took weight loss medication in the last 6 months.
  • Participated in Weight Watchers in last 2 years.
  • Lost \>=5% of body weight during 6 months prior to screening.
  • Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame.
  • Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study.
  • Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baruch College

New York, New York, 10010, United States

Location

Related Publications (1)

  • Pinto AM, Fava JL, Hoffmann DA, Wing RR. Combining behavioral weight loss treatment and a commercial program: a randomized clinical trial. Obesity (Silver Spring). 2013 Apr;21(4):673-80. doi: 10.1002/oby.20044.

MeSH Terms

Conditions

Obesity

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Angela M Pinto, PhD

    Baruch College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

November 1, 2008

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations