Status:
ENROLLING_BY_INVITATION
Consumption of More Ideal Food Options (COMIDA: Consumo de Opciones Más Ideales De Alimentos)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Make the Road New York (MRNY)
Mexican Coalition for the Empowerment of Youth and Families
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The Mexican Consulate runs a Ventanilla de Salud (VDS) (Health Window) program in fifty locations nationwide. The VDS provides an opportunity to provide health services to members of the Mexican commu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
1785 Patients enrolled
Trial Details
Trial ID
NCT03851458
Start Date
May 5 2015
End Date
May 1 2026
Last Update
June 10 2025
Active Locations (1)
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1
Mexican Consulate's Ventanilla de Salud (VDS)
New York, New York, United States, 10016