Lifestyle Intervention for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of the Vida Sana y Completa study is to provide evidence on the most effective approach for addressing the critical combination of obesity and food insecurity among Latinas in primary care while also collecting preliminary information on the potential for implementation and dissemination.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have recently changed your antidepressant medication, you must wait until your regimen is stable for at least 2 months before enrolling.
Is the Vida Sana program safe for humans?
The Vida Sana program, implemented by the Chilean Ministry of Health, involves activities like psychologist consultations, lifestyle workshops, and physical activity sessions. While the studies focus on effectiveness, they do not report any safety concerns, suggesting it is generally safe for participants.12345
What makes the Vida Sana y Completa treatment unique for obesity?
The Vida Sana y Completa treatment is unique because it focuses on a comprehensive lifestyle intervention, which includes coaching on physical activity, dietary behaviors, sleep, stress management, and behavioral change, rather than relying solely on medication or surgery. This approach aims to help individuals achieve and maintain a healthier lifestyle through both group and individual sessions.678910
What data supports the effectiveness of the treatment Vida Sana, Vida Sana y Completa for obesity?
Research shows that lifestyle interventions, which include a combination of diet, exercise, and behavioral changes, can effectively help with weight loss and reduce obesity-related health risks. Programs that focus on increasing physical activity and promoting healthy eating habits have been found to improve health even without significant weight loss.211121314
Who Is on the Research Team?
Lisa Goldman Rosas, PhD, MPH
Principal Investigator
Stanford University
Wei-ting Chen, PhD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for Latinas over 18 with obesity and food insecurity, having a BMI ≥30 kg/m2, high triglycerides or blood pressure, and other metabolic risks. Participants must be able to commit to the study for 24 months. Exclusions include recent antidepressant changes, lack of Spanish fluency, no reliable phone or internet access, plans to move away during the study period, certain medical conditions like severe comorbidities or active cancer within two years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Vida Sana or Vida Sana y Completa intervention, including 12 weekly group sessions, monthly phone sessions, and home visits. The Vida Sana y Completa group also receives weekly food box deliveries for the first 12 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with measurements taken at multiple time points.
What Are the Treatments Tested in This Trial?
Interventions
- Vida Sana
- Vida Sana y Completa
Vida Sana is already approved in United States for the following indications:
- Obesity prevention and management
- Diabetes prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
San Mateo Medical Center
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator