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Effectiveness of Brief Counseling for Weight Management

Effectiveness of Brief Counseling for Weight Management

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00212199
Enrollment
246
Registered
2005-09-21
Start date
2002-01-31
Completion date
2004-08-31
Last updated
2010-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Obesity

Keywords

Obesity Treatment, Effectiveness of weight management treatment, Counseling for weight management

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.

Detailed description

There is a growing demand for effective obesity treatments that don't require much time to implement especially in a primary health-care setting where time is especially limited. Brief interventions that might provide benefits similar to those produced by more time-intensive and costly lifestyle interventions would be very useful. There is also increasing interest in the efficacy of primary drug therapies for obesity. The purpose of this 12-month study, and 24-month follow-up, is to examine the efficacy of a brief behavioral counseling intervention alone or in combination with a drug already approved for the long-term management of obesity (orlisat)and compare both interventions to a drug alone condition.

Interventions

DRUGorlistat
BEHAVIORALBrief cognitive behavioral counseling

Sponsors

Hoffmann-La Roche
CollaboratorINDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
2. Changes in body mass index (BMI) at 6, 12 and 24 months.
1. Changes in body weight at 6, 12 and 24 months.

Secondary

MeasureTime frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026