Addressing Diabetes by Elevating Access to Nutrition (ADELANTE)

This study, called ADELANTE, is looking at whether a program called Vida Sana combined with healthy food deliveries can help Latino patients with type 2 diabetes better manage their blood sugar (HbA1c). Vida Sana is a group lifestyle program that includes family members and is designed with Latino cultural values in mind. You would receive 12 weeks of fresh vegetable and whole grain food deliveries from Dig Deep Farms. The study aims to see if this combination is more effective than usual care for improving blood sugar levels and reducing food insecurity. To join, you must be 18 or older, identify as Hispanic, Latino, Chicano, or Spanish, have type 2 diabetes, and have indicated food insecurity. The study plans to enroll 360 participants, but its current status is unclear.

Study design
This study is an interventional study with 360 planned participants. You and up to two household members would be randomly assigned to one of two groups.
What's involved
You would either receive 12 weeks of weekly food deliveries plus a 12-month remotely delivered lifestyle program (Vida Sana), or be in a control group that receives food deliveries 6 months later. Blood sugar (HbA1c) will be measured from when you start until 12 months later.
Compensation
Not stated in the trial record.
Follow-up
Your blood sugar (HbA1c) will be monitored for 12 months after you join the study.

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NCT05228860

Addressing Diabetes by Elevating Access to Nutrition

Recruiting
NAAges 18+InterventionalHealth services
Stanford University
~360 participants
Updated 2024-12-02 on ClinicalTrials.gov
What's tested:Vida Sana (a Group Lifestyle Intervention)Supplemental Healthy Food Deliveries

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HgbA1c
Measured over Baseline through 12 months post-enrollment
Diabetes
Obesity
Lifestyle, Healthy
1 sites across 1 states
California1
  • Lisa Goldman Rosas, PhD, MPH · PRINCIPAL_INVESTIGATOR · Stanford University

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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
  • HgbA1cBaseline through 12 months post-enrollment

    Study staff will gather fingerstick blood samples for HgbA1c.