Status:
COMPLETED
Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program.
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- 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
- 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 ≥ 6.5; those with HbA1c between 6-6.5% may complete an OGTT to rule out diabetes (glucose \<200 mg/dl)
- 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)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00960414
Start Date
August 1 2009
End Date
August 1 2013
Last Update
July 24 2024
Active Locations (1)
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1
Osher Center for Integrative Medicine
San Francisco, California, United States, 94115