- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00017706
Effectiveness of Primary Care Physicians in Delivering Weight Control Counseling
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatment of Obesity in the Primary Care Setting
This randomized clinical trial will determine the efficacy of physicians providing weight control advice to their overweight and obese patients in primary care practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Enrolled physicians are randomly assigned to receive brief training in either: 1) behavioral weight control intervention or 2) obesity education.
Enrolled patients are asked to see their physician for 2 weight control consultations during the year to discuss their weight and physical activity.
Regardless of the training the physician receives, the weight control advice is tailored to the individual patient.
Patients include men and women between the ages of 21 - 70 years, with a Body-Mass Index of 27 or greater, and they have met medical and other study eligibility criteria in order to safely participate.
As a participant in the trial, all patients are asked to attend an initial baseline assessment, and two follow-up assessments; 3 and 12 months after their first weight control consultation visit with their physician in order to evaluate any changes in their weight, waist circumference, physical activity, eating patterns, and mood.
The findings of this important study will shed light upon the role physician advice may have in helping overweight and obese patients lose weight and become more physically active.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh, GSPH
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body-Mass Index greater than or equal to 27
- Able to walk without assistance
- No untreated hypothyroidism or Cushing Disease
- No unstable medical or psychiatric condition
- No signs or symptoms of cardiovascular disease
- No history of gallstones
- No terminal illness
- No other acute or chronic medical condition in which weight loss is contraindicated
- Medically cleared for physical activity
Exclusion Criteria:
- Pregnant, nursing or planning to become pregnant in the next year
- Had an in-patient hospital stay in the last 3 months
- Lost more than 10 lbs in the last 4 months
- Taking an OTC or prescribed medication for weight loss
- In treatment for an eating disorder
- In treatment for depression (if patient is on an anti-depressant and has not had a recent episode of depression in the past 3 months then he/she is eligible)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laurey Simkin-Silverman, Ph.D., University of Pittsburgh, GSPH, Department of Epidemiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
May 1, 2001
Study Registration Dates
First Submitted
June 7, 2001
First Submitted That Met QC Criteria
June 6, 2001
First Posted (Estimate)
June 7, 2001
Study Record Updates
Last Update Posted (Estimate)
January 14, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Simkin-Silverman (completed)
- DK52050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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