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

NCT01242683 | Completed Phase 2 DMC

• 2 other identifiers: SU-10112010-7069R01HL089448
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 4

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 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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• body mass index

  24 months

Secondary Outcomes (4)

• blood lipid measurements

  24 months

• Fasting blood glucose

  24 months

• triglycerides

  24 months

• Hemoglobin A1c

  24 months

Study Arms (3)

Case-Management for Behavior Change

EXPERIMENTAL

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.

Behavioral: Vivamos Activos Fair Oaks Program

Case-Management plus Home Visits

EXPERIMENTAL

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.

Behavioral: Vivamos Activos Fair Oaks Program

Usual Primary Care

PLACEBO COMPARATOR

Continuation of usual primary care managed by the participants' usual physician or nurse practitioner source of care.

Behavioral: Vivamos Activos Fair Oaks Program

Interventions

Vivamos Activos Fair Oaks Program BEHAVIORAL

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.

Also known as: Modified and Tailored Diabetes Prevention Program Protocol

Case-Management for Behavior Change; Case-Management plus Home Visits; Usual Primary Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Stanford University: lead
• San Mateo Medical Center: collaborator
• El Concilio of San Mateo County: collaborator
• Palo Alto Medical Foundation: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

San Mateo Medical Center, Fair Oaks Adult Clinic

Redwood City, California, 94025, United States

Location

El Concilio of San Mateo

San Mateo, California, 94010-4123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 21320331 BACKGROUND

• 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.

  PMID: 24119533 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall S. Stafford MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Randall S. Stafford MD, PhD, Professor of Medicine

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 17, 2010
• Study Start: May 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

US (4)