Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05228860

Addressing Diabetes by Elevating Access to Nutrition: the ADELANTE Study

Led by Stanford University · Updated on 2024-12-02

360

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

L

La Clínica de La Raza Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether a combined approach of improving household food security and providing lifestyle coaching can help Latino adults with type 2 diabetes better control their blood sugar levels. The study, called ADELANTE, aims to see if weekly healthy food deliveries plus a culturally tailored lifestyle program called Vida Sana improve blood sugar control at 6 months compared to usual care. It also examines effects on food insecurity, diet habits, psychosocial factors, and the potential to implement this approach in primary care. Participants and up to two household members are randomly assigned to either receive weekly deliveries of healthy food for 12 weeks plus the 12-month Vida Sana lifestyle intervention delivered remotely via Zoom, or to a waitlist control group that receives usual care with no intervention for 6 months followed by food box deliveries without Vida Sana. Vida Sana includes 23 group sessions focused on calorie reduction, increased physical activity, behavior change strategies, and stress management, all led by bilingual health coaches. During the 12-month study, participants will complete assessments such as blood tests measuring HbA1c and cholesterol, blood pressure, body measurements, surveys on stress, quality of life, diet, physical activity, and food security. Researchers will monitor changes over time to evaluate the impact of the interventions. Household members also participate in some questionnaires and a group session. The study includes safety monitoring and lasts up to 12 months post-enrollment.

CONDITIONS

Brief Title

Addressing Diabetes by Elevating Access to Nutrition

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at enrollment
  • Self-identified as Hispanic, Latino, Chicano, or Spanish
  • Diagnosed with type 2 diabetes as recorded in health records
  • Experience household food insecurity based on a screening questionnaire
  • Body Mass Index (BMI) of 25 or higher
  • Receiving care at partnering community health centers
  • Currently living in Alameda or Contra Costa County and not planning to move in next 6-12 months
  • Have access to phone or computer, email, and internet for remote participation
  • Household members aged 12 years or older who support nutrition at home and can attend a group session
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Cannot speak, read, or understand English and/or Spanish
  • Active substance use or psychotic disorders affecting participation or follow-up
  • No mailing address for food box delivery
  • Planning to relocate out of the area within 12 months
  • Pregnant or planning pregnancy within 12 months (index participants only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Behavioral Intervention and Food Delivery

Duration - 12 months

Participants receive the Vida Sana lifestyle behavioral intervention along with weekly deliveries of healthy food boxes to their households.

23 group sessions over 12 months via Zoom and weekly food deliveries for 12 weeks

Food Delivery Only

Duration - 12 weeks

Participants receive weekly deliveries of healthy food boxes without the behavioral intervention.

Weekly food deliveries for 12 weeks

Trial Site Locations

Total: 1 location

1

La Clínica Monument

Concord, California, United States, 94518

Actively Recruiting

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Research Team

S

Study Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations.

Urmimala Sarkar, Dean Schillinger, Andrea López...

https://pubmed.ncbi.nlm.nih.gov/21057882

Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study.

Joan M Conway, Linda A Ingwersen, Alanna J Moshfegh

https://pubmed.ncbi.nlm.nih.gov/15054345

Development and Evaluation of the National Cancer Institute's Dietary Screener Questionnaire Scoring Algorithms.

Frances E Thompson, Douglas Midthune, Lisa Kahle...

https://pubmed.ncbi.nlm.nih.gov/28490673