Addressing Diabetes by Elevating Access to Nutrition
NCT05228860 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2024-12-02
Summary
The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes.
Specifically, ADELANTE aims to
1. determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months,
2. examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and
3. assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.
Conditions
Interventions
- BEHAVIORAL
-
Vida Sana (a Group Lifestyle Intervention)
Vida Sana is a Group Lifestyle intervention that has been shown to be effective among patients with type 2 diabetes (T2DM). Vida Sana includes 23 group sessions with a trained health coach: * Months 1-4: 1 family-wide orientation + 12 weekly sessions * Months 5-6: 4 bimonthly group sessions * Months 7-12: 6 monthly group sessions All regular primary care and diabetes care will remain as usual.
- BEHAVIORAL
-
Supplemental Healthy Food Deliveries
Participants will receive 12 weeks of weekly food deliveries from Dig Deep Farms. Each delivery will include a selection of seasonal fresh vegetables and a rotation of either a whole grain or a whole-grain food (3+ grams of fiber/serving). Whole grains will include brown rice, oatmeal, barley, quinoa; whole grain foods will include cereal, pasta, tortillas, bread, crackers. Delivery sizes will be scaled to the three corresponding household sizes: 2-3 people; 4-5 people; or 6 or more people. Food will be delivered by Dig Deep Farms, which already has an established food subscription delivery system. (Control group participants will receive the same delivery schedule, but delayed to begin 6 months after their study enrollment.)
Sponsors & Collaborators
-
La Clínica de La Raza Inc.
collaborator OTHER -
National Institutes of Health (NIH)
collaborator NIH -
Dig Deep Farms
collaborator UNKNOWN -
Yeyi Organics
collaborator UNKNOWN -
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH - lead OTHER
Principal Investigators
-
Lisa Goldman Rosas, PhD, MPH · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-18
- Primary Completion
- 2026-09-30
- Completion
- 2027-09-30
Countries
- United States
Study Locations
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