Clinical trial NCT03851458: Consumption of More Ideal Food Options (COMIDA: Consumo de Opciones Más Ideales De Alimentos)
Official title: Consumption of More Ideal Food Options (COMIDA: Consumo de Opciones Más Ideales De Alimentos)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Overweight
Obesity
Keywords: Focus Groups
15-088
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Make the Road New York (MRNY)
name: Mexican Coalition for the Empowerment of Youth and Families
name: The City College of New York
name: Mexican Consulate-NYC
name: Insight on Demand
First posted: 2019-02-22
Enrollment: 1785
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: self-reported measures on dietary intake
timeFrame: 1 year
measure: Decreasing weight by 5% [SANOS]
timeFrame: At 6 months post-intake
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mexican Consulate's Ventanilla de Salud (VDS)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Leng, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: