NCT05211180

Vida Sana y Completa Obesity and Food Insecurity Study

Vida Sana y Completa Trial: Treating Obesity and Food Insecurity Among Latina Women

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The goal of this study is to compare two approaches to addressing obesity and food insecurity among Latina women in primary care to provide evidence for community health centers who serve this high-priority group. The project team will recruit 412 low-income Latina women with obesity (body mass index 30) and food insecurity from two community health centers with whom the team has longstanding partnerships. Patients will be randomized to Vida Sana y Completa (an obesity intervention with integrated treatment for food insecurity) or Vida Sana alone. Vida Sana is a state-of-the-art cultural adaptation of Group Lifestyle Balance, a 12-month program that targets at least 5 percent weight loss and at least 150 minutes per week of moderate-to-vigorous physical activity. For food insecurity, the team will provide boxes of healthy foods (e.g., fresh produce, lean protein, low-fat dairy, and whole grains) that give women the foods they need to adopt a healthy diet.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Vida Sana	Weekly group or individual education sessions with a health coach and fitness tracking with a fitbit.
BEHAVIORAL	Vida Sana y Completa	Weekly group or individual education sessions with a health coach, fitness tracking with a fitbit, and weekly food box delivery.

Timeline

• Start date: 2022-09-27
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2022-01-27
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States