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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). The audio files will be transcribed and translated by research staff and/or MSK-approved AI transcription tool, Azure Speech in Foundry Tools. |
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| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | In-person individual diet and physical activity (PA) counseling |
| |
| 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:
| 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 |
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Inclusion Criteria:
For COMIDA participants only:
For SANOS focus group participants only:
For SANOS RCT participants only:
For Family COMIDA participants only:
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])
Owns a cell phone capable of receiving text messages
Agrees to be audio-recorded
For ROADmAP Phase 2 participants only:
Exclusion Criteria:
For COMIDA participants only:
For SANOS focus group participants only:
For SANOS RCT participants only:
For Family COMIDA participants only:
For ROADmAP RCT participants only:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Leng, MD,MPH | Contact | 646-888-8057 | lengj@mskcc.org | |
| Francesca Gany, MD, MS | Contact | 646-888-8054 |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Leng, MD, MPH | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mexican Consulate's Ventanilla de Salud (VDS) | Recruiting | New York | New York | 10016 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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|
| Text Messages |
| Behavioral |
Thrice-weekly diet/physical activity(PA) text messages |
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| Phone calls | Behavioral | Weekly telephone support |
|
| Self-monitoring tools | Behavioral | Self-monitoring tools |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |