Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)

The researchers will conduct 'Taxi ROADmAP (Realizing Optimization Around Diet And Physical activity)', which also utilizes MOST, and the same 4 obesity intervention components as in SANOS, but targets the overweight/obesity crisis in another at-risk, low socioeconomic status (SES) population, taxi and for-hire vehicle (FHV) drivers (Lyft, Uber, etc.). ROADMAP also utilizes an effectiveness- implementation hybrid type 1 design. Hybrid trials, which blend effectiveness and implementation studies, can lead to more rapid translational uptake and more effective implementation. Taxi and FHV drivers are a growing, multilingual, hard-to-reach, predominantly immigrant and minority essential worker population. There are over 750,000 licensed taxi and FHV drivers in in the U.S. and over 185,000 in New York City (NYC). They have higher rates of overweight/obese range body mass index (BMI) than New Yorkers in general (77% vs 56%) and have high rates of elevated waist circumference, sedentary behavior, poor diets, and health care services underutilization. ROADmAP will test 4 evidence- and theory-based (Social Cognitive Theory [SCT]) behavior change intervention components. We will use MOST to identify which of the 4 components contribute most significantly and cost-effectively to weight loss among NYC drivers recruited at workplace health fairs (HFs) and virtually. Objectives are to apply MOST to design an optimized version of a scalable, lifestyle intervention for taxi/FHV drivers, and then to conduct a mixed methods multistakeholder process evaluation to facilitate widespread intervention implementation.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight; Overweight and Obesity; Obese; Overweight or Obesity
• Intervention / Treatment: Behavioral: Counseling; Behavioral: Text Messages; Behavioral: Phone calls; Behavioral: Self-monitoring tools

• Study Type: Interventional
• Enrollment (Estimated): 1785
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jennifer Leng, MD,MPH; Phone Number: 646-888-8057; Email: lengj@mskcc.org
• Study Contact Backup: Name: Francesca Gany, MD, MS; Phone Number: 646-888-8054

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Mexican Consulate's Ventanilla de Salud (VDS)
      • Contact: Jennifer Leng, MD, MPH; Email: lengj@mskcc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Counseling; In-person individual diet and physical activity (PA) counseling; Behavioral: Text Messages; Thrice-weekly diet/physical activity(PA) text messages; Behavioral: Phone calls; Weekly telephone support; Behavioral: Self-monitoring tools; Self-monitoring tools
Other: 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.	Behavioral: Phone calls; Weekly telephone support
Other: 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).	Behavioral: Self-monitoring tools; Self-monitoring tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in participant body weight from baseline to 12 months	Efficacy of intervention is achieved when participants have weight loss with a minimum threshold of 5% of overall body weight lost Intervention components include: Initial in-person individual diet and physical activity (PA) counseling; Thrice-weekly diet/PA text messages; Weekly telephone support; Self-monitoring tools.	12-months post-intake
Estimate the cost and incremental cost-effectiveness of the obesity intervention components	Costs associated with each component include: 1) In-person counseling: personnel time, participant travel time, text messaging services; 3) Telephone support: personnel time; 4) Self-monitoring tools: food diaries and digital scales.	Up to 6 months
Feasibility of weight loss intervention for participants measured by the ROAmAP Process Evaluation Questionnaire	The ROADmAP Process Evaluation Questionnaire will be administered to all participants to gather data on implementation potential. Questions are on a Likert scale and will collect intervention delivery facilitators and barriers, intervention sustainability facilitators and barriers post-study completion. Feasibility will be indicated by extreme Likert scores (Strongly Agree, Neutral, Strongly Disagree).	Up to 12 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• 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): December 22, 2022
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): August 11, 2027

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Obese; Memorial Sloan Kettering Cancer Center; Focus Groups; Overweight and Obesity; Overweight or Obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: 15-088A(27)

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