Vivamos Activos Fair Oaks Program for Weight Loss in Low Income Latinos

Completed · Phase 2

Conditions studied: Obesity

In brief

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 evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, the investigators will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services

Key facts

Study ID

NCT01242683

Run by

Stanford University

People needed

207

Starts

2008-05-01

Expected to finish

2013-10-01

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Palo Alto Medical Foundation Research Institute — Palo Alto, California, United States
• San Mateo Medical Center, Fair Oaks Adult Clinic — Redwood City, California, United States
• El Concilio of San Mateo — San Mateo, California, United States
• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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