RecruitingNot ApplicableNCT05228860

Addressing Diabetes by Elevating Access to Nutrition

Addressing Diabetes by Elevating Access to Nutrition: the ADELANTE Study


Sponsor

Stanford University

Enrollment

360 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria15

  • For main study (index/intervention) participants:
  • Age at enrollment: 18+ years
  • Self-identified ethnicity: Hispanic, Latino, Chicano, or Spanish
  • Type 2 diabetes indicated in the electronic health record, e.g. as ICD-10 (International Classification of Diseases) diagnosis code or HbA1c value
  • Have indicated food insecurity according to the screening 2-item Hunger Vital Sign questionnaire
  • Have a Body Mass Index (BMI) => 25
  • Receiving care at our partnering community health centers (e.g., Clinica de la Raza)
  • Currently residing in Alameda or Contra Costa County and not expecting to relocate in the next 6-12 months
  • Have access to phone or computer, email, and some internet for access to remote intervention and completion of follow-up measures
  • For household members:
  • Age at enrollment: 12+ years
  • Significantly involved in supporting nutrition in the home including food shopping, preparation, social support for healthy nutrition
  • Willing to complete some questionnaires and attend a single group session.
  • For all participants:
  • Able and willing to provide informed consent

Exclusion Criteria6

  • Unable to provide informed consent
  • Unable to speak, read, or understand English and/or Spanish
  • Active substance use or psychotic disorders that would impair participation in a group lifestyle intervention or interfere with follow-up assessments
  • Lacking mailing address for delivery of food box
  • Planning to relocate out of area within the next 12 months
  • Index participant only: Pregnant or planning to become pregnant within the next 12 months

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Interventions

BEHAVIORALVida 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.

BEHAVIORALSupplemental 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.)


Locations(1)

La Clínica Monument

Concord, California, United States

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NCT05228860


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