Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05228860
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05228860
Study Brief:
Protocol Section:
NCT05228860