CompletedPhase 4

Effectiveness of Brief Counseling for Weight Management

United States246 participantsStarted 2002-01

Plain-language 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.

Who can participate

Age range

25 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT00212199

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More 1. Obesity trials

Who can participate

Age range

25 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.