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

Phase 2

Conditions: Obesity
Overweight

Interventions: Behavioral: Initial in-person individual diet and exercise counseling (N vs. Y)
Behavioral: Thrice weekly diet and exercise text messages (N vs. Y)
Behavioral: Weekly telephone support (N vs. Y)
Behavioral: Self-monitoring tools (N vs. Y) (for diet and weight)

Registration Number: NCT03851458

Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ENROLLING_BY_INVITATION

Sex: All

Target Recruitment: 1067

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 Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consumo de Opciones Mas Ideales De Alimento (COMIDA)	Initial in-person individual diet and exercise counseling (N vs. Y)	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.
Consumo de Opciones Mas Ideales De Alimento (COMIDA)	Thrice weekly diet and exercise text messages (N vs. Y)	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.
Consumo de Opciones Mas Ideales De Alimento (COMIDA)	Weekly telephone support (N vs. Y)	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.
Consumo de Opciones Mas Ideales De Alimento (COMIDA)	Self-monitoring tools (N vs. Y) (for diet and weight)	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.
SANOS	Initial in-person individual diet and exercise counseling (N vs. Y)	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).
SANOS	Thrice weekly diet and exercise text messages (N vs. Y)	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).
SANOS	Weekly telephone support (N vs. Y)	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).
SANOS	Self-monitoring tools (N vs. Y) (for diet and weight)	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).
ROADmAP schema	Initial in-person individual diet and exercise counseling (N vs. Y)	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).
ROADmAP schema	Thrice weekly diet and exercise text messages (N vs. Y)	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).
ROADmAP schema	Weekly telephone support (N vs. Y)	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).
ROADmAP schema	Self-monitoring tools (N vs. Y) (for diet and weight)	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).

Primary Outcome Measures

Name	Time	Method
self-reported measures on dietary intake	1 year	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).
Decreasing weight by 5% [SANOS]	At 6 months post-intake

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Mexican Consulate's Ventanilla de Salud (VDS)
🇺🇸
New York, New York, United States

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

Recruitment & Eligibility

Study & Design

Trial Locations

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