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Addressing Diabetes by Elevating Access to Nutrition
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:
🦠 Diabetes 🦠 Obesity 🦠 Lifestyle, Healthy
🗓️ Study Start (Actual) 18 September 2023
🗓️ Primary Completion (Estimated) September 2026
✅ Study Completion (Estimated) September 2027
👥 Enrollment (Estimated) 360
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Concord, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 January 2022
  • First Submitted that Met QC Criteria 27 January 2022
  • First Posted 8 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 September 2023
  • Last Update Posted 2 October 2023
  • Last Verified September 2023
I'm interested ...!!