Status:
COMPLETED
Vivamos Activos Fair Oaks Program for Weight Loss in Low Income Latinos
Lead Sponsor:
Stanford University
Collaborating Sponsors:
San Mateo Medical Center
El Concilio of San Mateo County
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Physician-based primary care has thus far failed to address the obesity epidemic. In this randomized clinical trial of 200 obese patients with heart disease risk factors, the investigators will evalua...
Detailed Description
Obesity is an epidemic in the U.S., with a third of adults obese. Obesity exerts enormous impact on the nation's health and economy largely through its effect on coronary heart disease (CHD) risk fact...
Eligibility Criteria
Inclusion
- Age 18 years or older;
- Body mass between 30 and 55 kg/m2
- One or more CHD risk factors: Systolic blood pressure between 130 and 200 mmHg; Diastolic blood pressure between 80 and 105 mmHg; Total cholesterol \> 180 mg/dL; LDL cholesterol \> 120 mg/dL; HDL Cholesterol \< 40 mg/dL; Triglycerides \> 150 mg/dL; HbA1c between 6.0 and 11.5%; Fasting plasma glucose between 95 and 400 mg/dL; Diagnosis of Type 2 diabetes
- Residing in catchment area of the Fair Oaks Adult Clinic and receiving primary care at Fair Oaks Adult Clinic.
Exclusion
- Inability to speak Spanish;
- Unwilling to attempt weight loss;
- Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, advanced heart failure, and ongoing substance abuse;
- On greater than 10 prescription medications;
- Psychiatric disorders requiring antipsychotics or multiple medications;
- Body weight change \> 25 lbs. in the preceding 3 months;
- Pregnant, planning to become pregnant, or lactating less than six months;
- Family household member already enrolled in the study;
- Intends to or is enrolled in a study that would limit full participation in VAFO;
- Participants who are unwilling to have home visits by study staff;
- Resident of a long term care facility;
- Plans to move during the study period (24 months post-randomization);
- Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT01242683
Start Date
May 1 2008
End Date
October 1 2013
Last Update
June 2 2014
Active Locations (4)
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1
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
2
San Mateo Medical Center, Fair Oaks Adult Clinic
Redwood City, California, United States, 94025
3
El Concilio of San Mateo
San Mateo, California, United States, 94010-4123
4
Stanford University School of Medicine
Stanford, California, United States, 94305