Consumption of More Ideal Food Options (COMIDA: Consumo de Opciones Más Ideales De Alimentos) (COMIDA)

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 community. Some of the concerns previously identified during the work at the VDS were that some individuals did not always get enough to eat, or do not always have enough money for food. This sometimes leads to unhealthy food choices-- buying and preparing foods that are inexpensive but really not good for the particpant. The investigators would like to conduct focus group to help make changes to a new diet and exercise program at the VDS called SANOS which stands for SAlud y Nutrición para todOS. SANOS aims to provide information for living a healthier lifestyle including on how to eat healthy on a small budget and how to become more physically active. The hope is that learning to eat healthy without spending a lot of money and to find simple ways to increase physical activity (like walking) will be a first step in reducing obesity rates within the Mexican community that have led to increased risks for cancer, cardiovascular disease, and diabetes.

Participants who reached 6-month follow-up during the COVID-19 pandemic, may be outside of the 12-month window post 6-month follow-up, and have not been able to complete HgbA1c and cholesterol measures will be invited to complete these measures in person at the VDS.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Overweight

• Study Type: Observational
• Enrollment (Estimated): 1067

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Mexican Consulate's Ventanilla de Salud (VDS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Recruitment for the COMIDA outreach intervention will be on location at the Mexican Consulate's Ventanilla de Salud (VDS) in Midtown Manhattan for those individuals who will remain in NYC during the study duration (3-4 months) as listed in the eligibility criteria. For the SANOS project, recruitment will be at the VDS and at the VDS Mobile Unit. Participants will also be recruited (in person or over the phone) using our existing database of prior VDS participants or from referrals of individuals seeking VDS services.

For the ROADmAP project, recruitment will be at IHCD's Health Fairs, at and with NYC taxi garage bases and FHV hubs (e.g., Uber, Lyft, Independent drivers Guild), all familiar sites through our prior work. Participants will also be recruited (in person or over the phone) using our existing database of prior Health Fairs participants or from referrals of individuals seeking Health Fair services.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Consumo de Opciones Mas Ideales De Alimento (COMIDA); Participants will be placed in either individual or group interventions by convenience. Recruitment will be consecutive and participants will be placed in either intervention depending on what resource is available on a given day at the VDS, individual counselor or a group educator.
ROADmAP schema; Participants will be randomly assigned to one of eight study groups which will be one or a combination of 4 conditions: (1) in person individualized diet and exercise counseling (2) diet and exercise text messages (3) weekly telephone support and (4) self-monitoring tools for diet and weight. For the first part of the study, Survey, approximately 64 drivers and 36 management staff will take pate in the feedback questionnaire. For the second part of the study, Interview, approximately 8 drivers and 12 management staff may be invited to take part in an interview via phone, in person, or teleconference (Zoom).
SANOS; Conducting SANOS Focus Groups. We will conduct 3-5 focus groups (in Spanish) with 6-10 participants each, until saturation. Bilingual study staff will approach individuals visiting the VDS and VDS Mobile for potential participation. A brief screening questionnaire will be administered, and a BMI assessment conducted, to ascertain eligibility. Focus groups will be scheduled at the VDS Mobile unit at times convenient to participants. Participants will be verbally consented in Spanish, and will be apprised that their participation is purely voluntary and that their names will not be included in the final narrative. The 6-month follow-up and my plate dietary surveys can be done over phone. Study staff will access step counts (or obtain it through phone via the pedometer manual provided to the participant) and upload data onto the REDCap tracking tool. Staff may ask participants to report step counts captured by their personal devices (i.e., phone or smartwatch).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-reported measures on dietary intake	Using the Dietary Screener of the 2011-12 California Health Interview Survey (CHIS)65 to measure diet behaviors of all participants. The information is collected through questions in the following format: "During the past month ["or in the past 7 days" for fast-food consumption], how often did you eat [food item name]?" The questions are often followed by clarification of the food items. The response is standardized to reflect mean per-week intake frequency. (Administration time ~ 10 minutes).	1 year
Decreasing weight by 5% [SANOS]		At 6 months post-intake

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: The City College of New York; Make the Road New York (MRNY); Mexican Coalition for the Empowerment of Youth and Families; Mexican Consulate-NYC; Insight on Demand
• Investigators: Principal Investigator: Jennifer Leng, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2015
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Focus Groups; 15-088
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 15-088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No