NCT05228860 · Stanford University
Addressing Diabetes by Elevating Access to Nutrition
(ADELANTE)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Concord, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 2, 2024 · Source of record for eligibility and locations