Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)

NCT05770570 | Recruiting Phase 2

• 1 other identifier: 15-088A(27)
• Study Type: interventional
• Target: 1,785
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Overweight or Obesity; Obesity; Obese; Overweight and Obesity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

ROADmAP schema

EXPERIMENTAL

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; Behavioral: Text Messages; Behavioral: Phone calls; Behavioral: Self-monitoring tools

Consumo de Opciones Mas Ideales De Alimento (COMIDA)

OTHER

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

SANOS

OTHER

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

Interventions

Counseling BEHAVIORAL

In-person individual diet and physical activity (PA) counseling

ROADmAP schema

Text Messages BEHAVIORAL

Thrice-weekly diet/physical activity(PA) text messages

ROADmAP schema

Phone calls BEHAVIORAL

Weekly telephone support

Consumo de Opciones Mas Ideales De Alimento (COMIDA); ROADmAP schema

Self-monitoring tools BEHAVIORAL

Self-monitoring tools

ROADmAP schema; SANOS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Mexican Consulate's Ventanilla de Salud (VDS)

New York, New York, 10016, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer Leng, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Leng, MD,MPH

CONTACT

646-888-8057; lengj@mskcc.org

Francesca Gany, MD, MS

CONTACT

646-888-8054

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 15, 2023
• Study Start: December 22, 2022
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): August 11, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF

Locations

US (1)