- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00177697
A Mentor-Based Approach to Long-Term Weight Loss
September 13, 2005 updated by: University of Pittsburgh
The purpose of this study to examine the effect of having a weight loss mentor on long-term weight loss in overweight adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
174
Phase
- Phase 2
- Phase 1
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
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15203
- University of Pittsburgh
-
-
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 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- 21-55 years of age
- BMI = 25-35 kg/m2
- Ability to provide informed consent.
- Ability to provide consent from their personal physician to participate in this study.
Exclusion Criteria:
- Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
- Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
- Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.)
- Non-medicated resting systolic blood pressure >160 mmHg or non-medicated resting diastolic blood pressure >100 mmHg, or taking medication that would affect blood pressure.
- Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
- Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
- History of myocardial infarction or valvular disease.
- History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
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
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
weight loss
|
Secondary Outcome Measures
Outcome Measure |
---|
fitness
|
dietary intake
|
mediators
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Start
September 1, 1999
Study Completion
July 1, 2002
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 15, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK058002 (NIH)
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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