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. Behavioral lifestyle interventions in primary care that target moderate weight loss (5-10 percent) and physical activity (150 minutes per week) are recommended to mitigate this risk. However, behavioral interventions in real-world primary care settings have been only modestly effective for Latina women. Food insecurity—the lack of consistent access to sufficient quantities of healthy food—disproportionately affects Latina women and especially those with obesity and at risk of chronic disease. Paradoxically, food insecurity is strongly associated with weight gain and obesity among women and particularly Latina women. Food insecurity limits adoption and maintenance of a healthy diet—the cornerstone of successful behavioral lifestyle interventions. 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.
Therefore, 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.
The intervention includes transition planning so that women can continue to access these healthy foods post-intervention. Participants will be assessed at baseline and every six months for 24 months. The primary outcome will be weight loss at 12 months. The team will also examine weight-loss maintenance over 24 months and secondary outcomes including patient-centered (e.g., general and obesity-specific quality of life) and behavioral (e.g., diet quality, physical activity) measures. The team will explore food insecurity severity as a potential moderator of intervention effectiveness.
In accordance with standards for studies of complex interventions, the team will conduct a mixed-methods process evaluation. A multi-sectoral community advisory board including patients, providers, healthcare system leaders, and other key stakeholders will be integrally involved in all phases of the research.