- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242683
Vivamos Activos Fair Oaks Program for Weight Loss in Low Income Latinos (VAFO)
Case-Management & Environmental Support to Sustain Weight Loss & Reduce CHD Risk
Study Overview
Status
Conditions
Intervention / Treatment
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 factors: 3 in 4 obese Americans have at least one CHD risk factor reversible through weight loss. Working within acute care-centered systems, most clinicians are unsuccessful in helping their patients lose weight or prevent weight gain. A promising and well-studied approach is integrated care delivered by nurse and dietitian case managers (CMs). Nonetheless, clinical prevention services (including CM) may be less effective if provided in isolation from patients' living environments that so often reinforce caloric excess and physical inactivity.
This application leverages our extensive expertise in developing and disseminating effective CM programs (Heart to Heart, R01 HL070781). We will implement an obesity-focused CM program that focuses on established behavioral weight loss and maintenance strategies and evidence-based CHD prevention targets. We also will test the additional benefit of structured "environmental support" (ES) carried out by community health workers that will bridge the gap between the clinic and patients' homes and neighborhood. Our Specific Aims are to:
- Implement innovative, primary care-based CM and CM+ES interventions in a randomized clinical trial. We will conduct this trial at a San Mateo Medical Center (SMMC) health center serving an ethnically diverse, low-income population. We will randomize 200 obese adults with at least one obesity-related CHD risk factor over 18 months to usual primary care (40 patients), CM alone (80), or CM+ES (80). Intervention patients in will receive an intensive weight loss and CHD risk intervention for 12 months, followed by 12 months of maintenance intervention.
- Determine the effectiveness and cost-effectiveness of the CM and CM+ES for improving BMI and CHD risk factors, relative to usual care and each other. Our PRIMARY HYPOTHESIS is that patients managed through CM+ES will experience greater reductions in BMI over 24-months than those in CM.
- Transition the favored intervention to a sustainable program, supported by the County, as well as explore opportunities for broader dissemination to other County and non-County systems. A business case for dissemination based on our findings will be critical in seeking this investment.
This project will develop and test two novel models of care design to support sustained weight loss. Given the failure of current mechanisms to address obesity and elevated CHD risk, these models have the potential to provide a blueprint for primary care-based obesity services that can reduce this nation's burden of obesity, especially for low-income populations.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94301
- Palo Alto Medical Foundation Research Institute
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Redwood City, California, United States, 94025
- San Mateo Medical Center, Fair Oaks Adult Clinic
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San Mateo, California, United States, 94010-4123
- El Concilio of San Mateo
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Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Case-Management for Behavior Change
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.
|
Comparison of Case-management vs. Case-management plus Home Visits vs. Usual Primary Care. Case-management: Five 60 minute individual and 15 90 minute group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. Home-visits: Seven home visits provided by a community health worker to provide life-style/environmental support for behavior change to facilitate weight loss. Usual primary care: Usual care provided at health center that is available to participants in all three study arms.
Other Names:
|
Experimental: Case-Management plus Home Visits
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.
|
Comparison of Case-management vs. Case-management plus Home Visits vs. Usual Primary Care. Case-management: Five 60 minute individual and 15 90 minute group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. Home-visits: Seven home visits provided by a community health worker to provide life-style/environmental support for behavior change to facilitate weight loss. Usual primary care: Usual care provided at health center that is available to participants in all three study arms.
Other Names:
|
Placebo Comparator: Usual Primary Care
Continuation of usual primary care managed by the participants' usual physician or nurse practitioner source of care.
|
Comparison of Case-management vs. Case-management plus Home Visits vs. Usual Primary Care. Case-management: Five 60 minute individual and 15 90 minute group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator. Home-visits: Seven home visits provided by a community health worker to provide life-style/environmental support for behavior change to facilitate weight loss. Usual primary care: Usual care provided at health center that is available to participants in all three study arms.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
body mass index
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin A1c
Time Frame: 24 months
|
24 months
|
blood lipid measurements
Time Frame: 24 months
|
24 months
|
Fasting blood glucose
Time Frame: 24 months
|
24 months
|
triglycerides
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Randall S. Stafford MD, PhD, Stanford University
Publications and helpful links
General Publications
- Drieling RL, Ma J, Stafford RS. Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program. BMC Public Health. 2011 Feb 14;11:98. doi: 10.1186/1471-2458-11-98.
- Drieling RL, Goldman Rosas L, Ma J, Stafford RS. Community resource utilization, psychosocial health, and sociodemographic factors associated with diet and physical activity among low-income obese Latino immigrants. J Acad Nutr Diet. 2014 Feb;114(2):257-265. doi: 10.1016/j.jand.2013.07.025. Epub 2013 Oct 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-10112010-7069
- R01HL089448 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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