Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons - NCT00960414-94115 (Clinical Trial 306080)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy306080.aspx
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| City: |
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San Francisco |
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State:
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CA |
| Zip Code: |
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94115 |
| Conditions: |
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Obesity |
| Purpose: |
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The purpose of this study is to compare two approaches to a diet and exercise-based weight
loss program.
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| Study summary: |
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The high prevalence of obesity and its medical consequences make it one of the most
important public health issues in the United States today. Few interventions have been
consistently successful at reducing obesity. This trial will test an intervention program
that lasts 22 weeks, with 16 evening sessions and two weekend days. Participants will be
randomized to one of two arms. Both arms will receive diet and exercise intervention
elements. The study aims for gradual weight loss, with a calorie target that will maintain
ideal body weight, rather than a more calorie restricted diet. The exercise component is
based around increasing walking. The arms will compare methods for producing long-lasting
behavior change. |
| Criteria: |
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Inclusion Criteria:
- Age 18+ years old
- BMI > 30-45
- Waist circumference > 102 cm (men) or > 88 cm (women)
- Live in San Francisco Bay Area and able to attend more than 16 classes and up to 12
assessment visits in San Francisco over an 18 month period
Exclusion Criteria:
- Inability to provide informed consent
- Age < 18
- A substance abuse, mental health, or medical condition that, in the opinion of
investigators, will make it difficult for the potential participant to participate in
the group intervention
- Type I or II Diabetes or fasting glucose ≥ 126 mg/dl or hemoglobin A1c ≥ 6
- Use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or
severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus),
that are likely to require these medications
- Use of immunosuppressive or immunomodulating drugs or chronic or acute conditions
that would require the use of such medications
- A history of known coronary artery disease (CAD), or typical or atypical anginal
chest pain requires a letter from the participant's physician that he or she has been
adequately evaluated and that a moderate exercise program is appropriate
- Non English speaker
- Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less
than 6 months post-partum
- Initiation of new class of psychiatric medications in past 2 months
- Currently on a specific weight loss diet
- For influenza vaccine administration: a prior allergic reaction to the influenza
vaccine or eggs. These participants can be included in the trial but will be
excluded from participation in influenza vaccination.
- Active bulimia or strong history of bulimia
- Current use of weight loss medications or supplements such as amphetamine-based drugs
that are believed to have some effect on weight
- History of or planned weight loss surgery
- Untreated hypothyroidism: TSH > 4mU/mL (or the upper limit of normal reference
defined by the lab doing the assay) |
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| Study is available at: |
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Osher Center for Integrative Medicine
San Francisco, CA 94115
United States
Primary Contact:
Patricia Moran, PhD
Email: moranp@ocim.ucsf.edu
Phone: 415-353-9745 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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