Optimizing diet and physical activity for taxi drivers

Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)

This study is trying to help taxi drivers who are overweight or obese make healthier choices about their diet and exercise through personalized support and tools.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1785 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05770570 on ClinicalTrials.gov

What this trial studies

This study aims to address the obesity crisis among taxi and for-hire vehicle drivers, a population that is predominantly low socioeconomic status and has high rates of overweight and obesity. Utilizing a hybrid effectiveness-implementation design, the study will incorporate counseling, text messages, phone calls, and self-monitoring tools to promote healthier lifestyle choices. Participants will be recruited from the Mexican Consulate's Ventanilla de Salud in New York City, focusing on those who self-identify as Mexican American or Hispanic/Latino and prefer to communicate in Spanish. The study seeks to improve health outcomes in a hard-to-reach population through tailored interventions.

Who should consider this trial

Good fit: Ideal candidates are Hispanic/Latino adults aged 18 and older who are overweight or obese and seeking services at the Mexican Consulate.

Not a fit: Patients who do not identify as Hispanic/Latino or those who do not meet the BMI criteria for overweight or obesity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to significant improvements in weight management and overall health for taxi and for-hire vehicle drivers.

How similar studies have performed: Other studies targeting similar populations with tailored interventions have shown promise, suggesting that this approach could be effective.

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
* Is currently taking Ozempic, Wegovy, Mounjaro, Rybelsus, Trulicity Saxenda, Victoza, Phentermine (Adipex, Lomaira), Extended-release Phentermine/Topiramate (Qsymia), Extended-release Naltrexone/Bupropion (Contrave), Plenity, Orlistat (Xenical) or Other GLP-1 receptor agonist, or any other drug to treat obesity or there is less than 7 weeks since last dosage.
* Has undergone weight loss/bariatric surgery or is planning to undergo such surgery in the next 12 months.

Where this trial is running

New York, New York

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

Study contacts

• Principal investigator: Jennifer Leng, MD, MPH — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jennifer Leng, MD,MPH

Conditions Overweight; Overweight and Obesity; Overweight or Obesity; Obesity; Obese; Focus Groups; Memorial Sloan Kettering Cancer Center