Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Vivamos Activos Fair Oaks Program

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Age 18 years or older;

   2. Body mass between 30 and 55 kg/m2

   3. 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

   4. Residing in catchment area of the Fair Oaks Adult Clinic and receiving primary care at
   Fair Oaks Adult Clinic.

Exclusion Criteria:

   1. Inability to speak Spanish;

   2. Unwilling to attempt weight loss;

   3. Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g.,
   thyroid, diabetes, renal, liver), unstable heart disease, advanced heart failure, and
   ongoing substance abuse;

   4. On greater than 10 prescription medications;

   5. Psychiatric disorders requiring antipsychotics or multiple medications;

   6. Body weight change > 25 lbs. in the preceding 3 months;

   7. Pregnant, planning to become pregnant, or lactating less than six months;

   8. Family household member already enrolled in the study;

   9. Intends to or is enrolled in a study that would limit full participation in VAFO;

10. Participants who are unwilling to have home visits by study staff;

11. Resident of a long term care facility;

12. Plans to move during the study period (24 months post-randomization);

13. Investigator discretion for clinical safety or adherence reasons (e.g., unstable
   housing, chronic pain).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Randall Stafford
6507242400
Not Recruiting