Vida Sana y Completa

Close to half of the 30 million Latina women in the United States (US) have obesity, substantially increasing their risk for costly and debilitating chronic conditions such as diabetes. The US Preventive Services Task Force recommends behavioral lifestyle interventions in primary care that target moderate weight loss (5-10%) to mitigate this risk. However, behavioral interventions in real-world primary care settings among Latina women have been only modestly effective. Food insecurity limits the adoption and maintenance of a healthy diet – the cornerstone of successful behavioral lifestyle interventions.

However, there is extremely limited evidence to inform how primary care settings can best address food insecurity in the context of behavioral lifestyle interventions for obesity for Latina women. 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.

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 cultural adaption of Group Lifestyle Balance, a 12-month program that targets at least 5% weight loss and at least 150 minutes per week of moderate-to-vigorous physical activity. A trained health coach provides personalized feedback on self-tracking emphasizing moderate caloric reduction by 500-1,000 calories per day through healthy substitutions, incremental increases in moderate physical activity, and behavioral strategies to support successful adoption and maintenance of health behaviors. Behavioral strategies include realistic goal setting, fostering social support, and stress management.

The Vida Sana y Completa group will be provided with 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. Food boxes, sized for the household, provide healthy food to reduce food insecurity. They also enable patients and their families to try new healthy foods and meals with less economic risk. Finally, the food boxes also connect patients to local food resources for accessing healthy food post-intervention. The food boxes will include foods available in low-cost grocery chains accessible to low-income Latina patients.

Participants will be assessed at baseline and every 6 months for 24 months. The primary outcome will be weight loss at 12 months. We will also examine weight loss maintenance over 24 months and other secondary outcomes including patient-centered (e.g., general and obesity-specific quality of life) and behavioral (e.g., diet quality, physical activity) measures. We will explore food insecurity severity as a potential moderator of intervention effectiveness. Lastly, we will conduct a mixed methods process evaluation according to the Consolidated Framework for Implementation Research (CFIR) that will identify facilitators and barriers for future implementation and dissemination in healthcare settings.