1. ObesityPhase 4NCT00212199
Effectiveness of Brief Counseling for Weight Management
A Phase 4 study testing orlistat and Brief cognitive behavioral counseling in people with 1. Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- 1. Obesity
- What is being tested?
- orlistat and Brief cognitive behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Aug 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- 1. Obesity
- Being tested
- orlistat, Brief cognitive behavioral counseling
- Keywords
- Obesity Treatment, Effectiveness of weight management treatment, Counseling for weight management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orlistatDrug
Brief cognitive behavioral counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2002
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1. ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Investigators
- John P Foreyt, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212199
- Sponsor's protocol ID
- DK58299 (completed 2205)
- Status last verified
- Mar 2010
- First submitted
- 13 Sep 2005
- Last updated
- 18 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Brief Counseling for Weight Management
- ClinicalTrials.gov ID
- NCT00212199
- Acronym / sponsor ID
- DK58299 (completed 2205)
- Conditions
- 1. Obesity
- Keywords
- Obesity Treatment, Effectiveness of weight management treatment, Counseling for weight management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Study start
- Jan 2002
- Study completion
- Aug 2004 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orlistat | Drug | – |
| Brief cognitive behavioral counseling | Behavioural | – |
Primary outcome
1. Changes in body weight at 6, 12 and 24 months.
2. Changes in body mass index (BMI) at 6, 12 and 24 months.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Foreyt, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing orlistat and Brief cognitive behavioral counseling in people with 1. Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Changes in body weight at 6, 12 and 24 months.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2010.