TY - JOUR
AU - L. G. Rosas
AU - J. A. Perez
AU - W. T. Chen
AU - L. Xiao
AU - Rodriguez Espinosa
AU - E. M. Venditti
AU - M. A. Lewis
AU - C. D. Gardner
AU - A. Marti
AU - E. Martinez
AU - M. Murthy
AU - M. Hauser
A1 - 
AB - Latina women have a high prevalence of obesity and obesity-related chronic diseases, such as diabetes. Approximately half of Latinas with obesity will also experience food insecurity, or a lack of access to enough food for an active and healthy life. Food insecurity is a barrier for effective prevention and management of obesity-related chronic diseases. The goal of this type 1 hybrid comparative effectiveness trial is to compare a culturally-tailored diabetes prevention intervention with and without medically supportive groceries. Adult Latina women (n = 412) with obesity (Body Mass Index (BMI) of >30 kg/m(2)) and food insecurity will be 1:1 randomized to the Vida Sana intervention (control), or to Vida Sana y Completa (intervention plus integrated treatment for food insecurity). Vida Sana is an evidence-based culturally tailored, 12-month diabetes prevention intervention that targets at least 5% weight loss and at least 150 min/week of moderate-to-vigorous physical activity. Participants enrolled in Vida Sana y Completa will also receive 12 weekly deliveries of medically supportive groceries. Those in Vida Sana alone will receive information on local food resources. Participants will be assessed at baseline and every 6 months for 24 months. The primary outcome is weight loss at 12 months. Secondary outcomes include weight loss maintenance, diet quality, and quality of life. Barriers and facilitators of implementation will be assessed using mixed methods according to the Consolidated Framework for Implementation Research. This study will provide critical evidence for addressing the combination of obesity and food insecurity in primary care for diabetes prevention. Trial Registration: NCT052111.
AD - Stanford University School of Medicine, 1701 Page Mill Road, Palo Alto, CA 94304, USA. Electronic address: lgrosas@stanford.edu.; Stanford University School of Medicine, 1701 Page Mill Road, Palo Alto, CA 94304, USA.; University of Pittsburgh, 100 N. Bellefield Ave., 8th floor, suite 830, Pittsburgh, PA 15213, USA. Electronic address: vendittiem@upmc.edu.; RTI International, Seattle, WA 98104, USA. Electronic address: melewis@rti.org.; Second Harvest of Silicon Valley, 750 Curtner Ave, Palo Alto, CA 95125, USA. Electronic address: mmurthy@shfb.org.
AN - 38810932
BT - Contemp Clin Trials
C5 - Healthcare Disparities
DA - Aug
DO - 10.1016/j.cct.2024.107582
DP - NLM
ET - 20240527
JF - Contemp Clin Trials
LA - eng
N2 - Latina women have a high prevalence of obesity and obesity-related chronic diseases, such as diabetes. Approximately half of Latinas with obesity will also experience food insecurity, or a lack of access to enough food for an active and healthy life. Food insecurity is a barrier for effective prevention and management of obesity-related chronic diseases. The goal of this type 1 hybrid comparative effectiveness trial is to compare a culturally-tailored diabetes prevention intervention with and without medically supportive groceries. Adult Latina women (n = 412) with obesity (Body Mass Index (BMI) of >30 kg/m(2)) and food insecurity will be 1:1 randomized to the Vida Sana intervention (control), or to Vida Sana y Completa (intervention plus integrated treatment for food insecurity). Vida Sana is an evidence-based culturally tailored, 12-month diabetes prevention intervention that targets at least 5% weight loss and at least 150 min/week of moderate-to-vigorous physical activity. Participants enrolled in Vida Sana y Completa will also receive 12 weekly deliveries of medically supportive groceries. Those in Vida Sana alone will receive information on local food resources. Participants will be assessed at baseline and every 6 months for 24 months. The primary outcome is weight loss at 12 months. Secondary outcomes include weight loss maintenance, diet quality, and quality of life. Barriers and facilitators of implementation will be assessed using mixed methods according to the Consolidated Framework for Implementation Research. This study will provide critical evidence for addressing the combination of obesity and food insecurity in primary care for diabetes prevention. Trial Registration: NCT052111.
PY - 2024
SN - 1551-7144
SP - 107582
ST - Vida Sana y Completa: A randomized controlled trial to examine the effectiveness of diabetes prevention with and without medically supportive groceries among Latina women
T1 - Vida Sana y Completa: A randomized controlled trial to examine the effectiveness of diabetes prevention with and without medically supportive groceries among Latina women
T2 - Contemp Clin Trials
TI - Vida Sana y Completa: A randomized controlled trial to examine the effectiveness of diabetes prevention with and without medically supportive groceries among Latina women
U1 - Healthcare Disparities
U3 - 10.1016/j.cct.2024.107582
VL - 143
VO - 1551-7144
Y1 - 2024
ER -