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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03851458
Eligibility Criteria:
Inclusion Criteria:
For COMIDA participants only:
* Self-Identifies as Mexican American or Mexican
* Seeking services at the VDS of the Mexican Consulate
* Prefers to speak in Spanish
* All adults at least 18 years of age
* Screens as obese (an adult who has a Body Mass Index (BMI) 30 or higher) or overweight (an adult who has a BMI between 25 - 29.9)
* Agrees to be audio recorded
For SANOS focus group participants only:
* Self-identifies as Hispanic/Latino;
* Seeking services at VDS or VDS Mobile;
* Prefers to speak in Spanish;
* At least 18 years of age;
* Screens as obese (BMI ≥ 30 kg/m\^2) or overweight (BMI of 25 - 29.9 kg/m\^2);
* Agrees to be audio recorded
For SANOS RCT participants only:
* Self-identifies as Hispanic/Latino;
* Seeking services at VDS or VDS Mobile;
* Prefers to speak in Spanish;
* At least 18 years of age;
* Screens as obese (BMI ≥ 30 kg/m\^2) or overweight (BMI of 25 - 29.9 kg/m\^2);
* Owns a cell phone capable of receiving text messages;
* Agrees to be audio recorded
For Family COMIDA participants only:
* Self-Identifies as Hispanic/Latino
* Seeking services at the VDS (or has used VDS services in the past) of the Mexican Consulate or VDS Mobile
* Prefers to speak in Spanish
* At least 18 years of age
* Has at least one child under age 18 living in the same household
* Owns a cell phone capable of receiving text messages
* Willing to receive text messages (3 texts per week for 3 months)
* Owns an internet connected device (eg, cell phone, tablet, etc) capable of conducting teleconference calls (eg, Zoom)
For ROADmAP RCT participants only:
* At least 21 years of age
* Full-time (drives at least 35 hours per week) licensed taxi/FHV driver
* Driver for at least 6 months
* Seeking Health Fairs (or has used Health Fairs services in the past)
* Speaks English, French, Bengali, or Spanish
* Screens a as obese (BMI ≥ 30 kg/m2 \[≥25 kg/m2 for South Asians\]) or overweight (BMI of 25 - 29.9 kg/m2 s \[23- 24.9 kg/m2 for South Asians\])
* (BMI cut-offs are lower for South Asians, per WHO and American Diabetes Association recommendations)
* Owns a cell phone capable of receiving text messages
* Agrees to be audio-recorded
For ROADmAP Phase 2 participants only:
* At least 21 years of age
* Driver who participated in ROADmAP RCT or manager at a taxi garage, Uber, Lyft or driver serving/union/organization
* Agrees to be audio-recorded
Exclusion Criteria:
For COMIDA participants only:
* Will not be in the NYC area for the study duration (3-4 months) Is pregnant or might be pregnant
* Lactating women
* Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (Individuals with diabetes, lactose intolerance, and high blood pressure MAY still participate in the study)
* Has dietary restrictions (i.e. liquid diet)
* Does not have a phone that accepts text messages or unwilling to accept text messages
* Presence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional"s judgment
* Has another family member already enrolled in COMIDA (as determined by patient report)
For SANOS focus group participants only:
* Is pregnant or might be pregnant; lactating women;
* Self-reported presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with HTN and DM may still participate);
* Has dietary restrictions (i.e. liquid diet);
* Has a household member who has already participated (or agreed to participate);
For SANOS RCT participants only:
* Is pregnant or might be pregnant; lactating women; for the study duration (6 months)
* Self-reported presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with HTN and DM may still participate); restricting diet;
* Currently has dietary restrictions (i.e. liquid diet);
* Has a household member who has already participated (or agreed to participate);
* Has already participated in the study
* Will not be in the NY Metropolitan area for the study duration (6 months) Works for or with the Mexican consulate (including employment and/or collaborative or volunteer services)
For Family COMIDA participants only:
* Is pregnant or might be pregnant; lactating women for the study duration (3 months)
* Will not be in the NY Metropolitan area for the study duration (3 months) Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (Individuals with diabetes, lactose intolerance, and high blood pressure MAY still participate in the study)
* Has dietary restrictions (i.e. liquid diet)
* Has another family member who has already participated in COMIDA or SANOS
* Has already participated in the study
* Works for or with the Mexican consulate (including employment and/or collaborative or volunteer services)
For ROADmAP RCT participants only:
* Is pregnant or might be pregnant; lactating women; for the study duration (12 months)
* Self-reported presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with HTN and DM may still participate) that may restrict diet
* Currently has dietary restrictions (i.e. liquid diet)
* Has a household member who has already participated (or agreed to participate)
* Has already participated in the study
* Will not be in the NY Metropolitan area for 6 months from study enrollment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03851458
Study Brief:
Protocol Section:
NCT03851458