NCT05228860 Addressing Diabetes by Elevating Access to Nutrition
| NCT ID | NCT05228860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2023-09-18 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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 Criteria
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
Contact & Investigator
Lisa Goldman Rosas, PhD, MPH
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05228860 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05228860 currently recruiting?
Yes, NCT05228860 is actively recruiting participants. Contact the research team at morizaga@stanford.edu for enrollment information.
Where is the NCT05228860 trial being conducted?
This trial is being conducted at Concord, United States.
Who is sponsoring the NCT05228860 clinical trial?
NCT05228860 is sponsored by Stanford University. The principal investigator is Lisa Goldman Rosas, PhD, MPH at Stanford University. The trial plans to enroll 360 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.