Status:
RECRUITING
Addressing Diabetes by Elevating Access to Nutrition
Lead Sponsor:
Stanford University
Collaborating Sponsors:
La Clínica de La Raza Inc.
National Institutes of Health (NIH)
Conditions:
Diabetes
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, ADELANT...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05228860
Start Date
September 18 2023
End Date
September 1 2027
Last Update
December 2 2024
Active Locations (1)
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1
La Clínica Monument
Concord, California, United States, 94518