Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)

Obesity Clinical Trial

Official title:

Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770570
• Other study ID #: 15-088A(27)
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2022
• Est. completion date: August 11, 2026

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jennifer Leng, MD,MPH
• Phone: 646-888-8057
• Email: lengj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1067
• Est. completion date: August 11, 2026
• Est. primary completion date: January 11, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

• Has not been prescribed Ozempic, Wegovy, Mounjaro, Rybelsus, Trulicity (or other GLP-1 receptor agonist), or any other drug to treat obesity.

Related Conditions & MeSH terms

• Obese
• Obesity
• Overweight
• Overweight and Obesity
• Overweight or Obesity

Intervention

Behavioral:
• Counseling
In-person individual diet and physical activity (PA) counseling
• Text Messages
Thrice-weekly diet/physical activity(PA) text messages
• Phone calls
Weekly telephone support
• Self-monitoring tools
Self-monitoring tools

Locations

Country	Name	City	State
United States	Mexican Consulate's Ventanilla de Salud (VDS)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center