NCT00212199

Brief Summary

The purpose of this study is to test the effectiveness of three different methods for delivering weight management information. Two methods utilize an obesity drug and the third method utilizes brief behavioral counseling sessions only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

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

January 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

First QC Date

September 13, 2005

Last Update Submit

March 17, 2010

Conditions

1. Obesity

Keywords

Obesity TreatmentEffectiveness of weight management treatmentCounseling for weight management

Outcome Measures

Primary Outcomes (2)

  • 1. Changes in body weight at 6, 12 and 24 months.

  • 2. Changes in body mass index (BMI) at 6, 12 and 24 months.

Secondary Outcomes (3)

  • 1. Changes in blood pressure at 6, 12 and 24 months.

  • 2. Changes in lipids at 6, 12 and 24 months.

  • 3. Changes in serum glucose at 6, 12 and 24 months.

Interventions

orlistatDRUG
Brief cognitive behavioral counselingBEHAVIORAL

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index of 30 to 40
  • Male or females ages of 25 to 55 years
  • Normal blood pressure or controlled with medicine
  • Females not lactating, able to get pregnant or using acceptable birth control
  • Current allowed medications prescribed at least 2 months prior to study

You may not qualify if:

  • Pregnant, planning to get pregnant or becomes pregnant
  • Insulin dependent diabetes
  • Uncontrolled hypertension
  • Prescence or history of significant medical conditions that could impact the outcome of the study
  • Prescence of active gastrointestinal disorders
  • History of mental disorders including eating disorders
  • Weight loss greater than 10 pounds in the last 3 months
  • History of alcohol or drug dependency
  • Use of any weight-loss medication in the last 6 months
  • Known allery to orlistat or any of its components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Orlistat

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • John P Foreyt, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2002

Study Completion

August 1, 2004

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

US(1)