Consumption of More Ideal Food Options (COMIDA: Consumo de Opciones Más Ideales De Alimentos) (NCT03851458) | Clinical Trial Compass
By InvitationPhase 2
Consumption of More Ideal Food Options (COMIDA: Consumo de Opciones Más Ideales De Alimentos)
United States1,785 participantsStarted 2015-05-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.