NCT05228860

Addressing Diabetes by Elevating Access to Nutrition

Addressing Diabetes by Elevating Access to Nutrition: the ADELANTE Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants and up to two of their household members will be randomized to one of two groups: 1. healthy food box home delivery for 12 weeks plus a 12-month remotely delivered lifestyle behavioral intervention, Vida Sana, which incorporates family members and is aligned with Latino cultural values, or 2. a wait list control group who will receive the food box deliveries 6 months later (but not the Vida Sana intervention). The first 6 months will evaluate the effects of receiving Vida Sana plus food delivery versus being randomized to control (no intervention); the final 6 months will evaluate receiving food delivery with versus without Vida Sana. VIDA SANA (intervention arm): The Vida Sana intervention is a cultural adaptation of Group Lifestyle Balance, a 12-month group program in turn adapted from the NIH/NIDDK-supported Diabetes Prevention Program (DPP). It has been shown to be effective in promoting clinically significant, modest weight loss and significant improvements in moderate-intensity physical activity. Participants receive a total of 23 group sessions over 12 months with a trained health coach who provides personalized feedback based on self-tracking. The program emphasizes a) moderate caloric reduction by 500-1,000 calories per day through healthy substitutions, b) incremental increases in moderate physical activity such as brisk walking, and c) behavioral strategies to support successful adoption and maintenance of healthy behaviors. These behavioral strategies include realistic goal setting, fostering social support, and stress management. Study health coaches will also add COVID-specific topics to ensure that participants are equipped to change behavior and manage stress during the pandemic. FOOD BOXES (intervention arm (immediately) and control arm (6 months later)): Each healthy food box delivery will include a variety of seasonal produce and a rotation of different whole grain foods (3+ grams of fiber/serving) such as cereal, pasta, tortillas, bread, and crackers. Participants will receive familiar foods as well as (intentionally) unfamiliar items to encourage them to try new foods. All items are also available at low-cost grocery stores so participants can continue to purchase them after the end of the study if they wish. The quantity is scaled to three household sizes. It is intended to supplement a family's food supply and provide opportunities for trying new fiber-rich foods recommended by the Vida Sana intervention.

Conditions

• Diabetes
• Obesity
• Lifestyle, Healthy

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2023-09-18
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2022-02-08
• Last updated: 2024-12-02

Locations

1 site across 1 country: United States