Addressing Diabetes by Elevating Access to Nutrition

Part of paid clinical trials in Concord, California.

Sponsor
Stanford University
Study ID
NCT05228860
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vida Sana (a Group Lifestyle Intervention) — BEHAVIORAL
    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.
  • Supplemental Healthy Food Deliveries — BEHAVIORAL
    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.)

Study Details

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.

Key Dates

Start date
Sep 18, 2023
Status verified
Nov 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Food and Lifestyle Intervention Group
    The Food and Lifestyle Intervention Group will receive weekly household deliveries of healthy food as well as a lifestyle intervention (called Vida Sana) that will be delivered via Zoom and facilitated by a trained bilingual/bicultural health coach.
  • Experimental: Waitlist Control Group
    The waitlist control will continue usual care with no intervention for 6 months. To balance rigor with ethical considerations, they will receive the healthy food box deliveries after a 6 month waiting period.

Primary Outcome Measure

HgbA1c [ Time Frame: Baseline through 12 months post-enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
La Clínica MonumentConcordCalifornia94518-

Find similar trials in Concord, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
La Clínica Monument· Concord, CA

Related Studies