Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Nearly half of the 30 million Latina women in the United States have obesity. Obesity can lead to serious health problems such as high blood pressure, diabetes, and heart disease. Losing weight can help reduce the risk of these health problems and improve quality of life.

Many Latina women experience food insecurity, or not having regular access to low-cost, healthy foods. Not having enough healthy food makes it hard to adopt a diet that promotes weight loss and prevents chronic disease.

In this study, the research team wants to know how well a weight loss program with or without food assistance helps Latina women with obesity lose weight. The program helps Latina women learn about and take part in weight loss habits like getting regular exercise and eating healthy foods.

Who can this research help?

Results may help community health centers who serve Latina women with obesity and food insecurity when considering options for weight loss.

What is the research team doing?

The research team is recruiting 412 Latina women with obesity and food insecurity. The women are patients from two community health centers in California. The team is assigning women by chance to receive either Vida Sana or Vida Sana y Completa. Both programs last for one year and center around Latina women’s culture and values.

Vida Sana is a one-year weight loss program that helps people learn how to lose weight through education, social support, and coaching. During the first three months, a health coach leads women in weekly one-hour group education sessions. Health coaches also visit the women at home at the start of the study and again three months later. Then, health coaches follow up with the women through monthly phone sessions until the end of the program. The two main goals of the program are to help women achieve 5 percent weight loss and get at least 150 minutes of exercise each week. The women are tracking their exercise with Fitbits. A Fitbit is an activity tracker worn on the wrist. They are also learning how to monitor their weight on their own. During sessions with health coaches, women receive custom feedback based on their Fitbit data.

Vida Sana y Completa is the same as Vida Sana but also includes food assistance. Women in this program are having a box of food delivered to them each week for the first three months of the study. Boxes have fresh produce, lean protein, low-fat dairy, and whole grains. The research team is helping women plan to keep eating healthy foods when the study ends.

The research team is tracking the women’s weight loss by weighing them at the start of the study and one year later. The women are also reporting their own weight after 6 and 18 months. Finally, the team is surveying the women about their diet and quality of life.

Patients with obesity, doctors, and healthcare system representatives are giving input on the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 412 adult, Latina women with low incomes and obesity (body mass index = 30) and food insecurity
Interventions/
Comparators
  • Vida Sana
  • Vida Sana y Completa
Outcomes

Primary: weight

Secondary: self-reported weight; visit or electronic health record height, waist circumference; health-related quality of life; obesity-specific quality of life; change in psychosocial well-being; cardiometabolic risk factors; medication use; dietary intake patterns; physical activity recall; self-reported steps per day (recorded via Fitbit); food security; anxiety; food and health literacy

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 1-year follow-up for primary outcome

Project Information

Lisa Rosas, PhD, MPH
Board of Trustees of the Leland Stanford Junior University
$4,114,445
Vida Sana y Completa Trial: Treating Obesity and Food Insecurity Among Latina Women

Key Dates

July 2021
December 2027
2021

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: October 18, 2023