Vivamos Activos Fair Oaks Program for Weight Loss in Low Income Latinos (VAFO)
Obesity
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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).
Sites / Locations
- Palo Alto Medical Foundation Research Institute
- San Mateo Medical Center, Fair Oaks Adult Clinic
- El Concilio of San Mateo
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Case-Management for Behavior Change
Case-Management plus Home Visits
Usual Primary Care
Individual and group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. 12 month of intensive intervention followed by 12 months of maintenance intervention.
Community health worker lifestyle support for weight loss strategies conducted in participants' homes and neighborhood. Also, receive individual and group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. 12 month of intensive intervention followed by 12 months of maintenance intervention.
Continuation of usual primary care managed by the participants' usual physician or nurse practitioner source of care.