Trial Title:
Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)
NCT ID:
NCT05770570
Condition:
Overweight
Overweight and Obesity
Overweight or Obesity
Obesity
Obese
Conditions: Official terms:
Obesity
Overweight
Conditions: Keywords:
Focus Groups
Overweight
Overweight and Obesity
Overweight or Obesity
Obesity
Obese
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Counseling
Description:
In-person individual diet and physical activity (PA) counseling
Arm group label:
ROADmAP schema
Intervention type:
Behavioral
Intervention name:
Text Messages
Description:
Thrice-weekly diet/physical activity(PA) text messages
Arm group label:
ROADmAP schema
Intervention type:
Behavioral
Intervention name:
Phone calls
Description:
Weekly telephone support
Arm group label:
Consumo de Opciones Mas Ideales De Alimento (COMIDA)
Arm group label:
ROADmAP schema
Intervention type:
Behavioral
Intervention name:
Self-monitoring tools
Description:
Self-monitoring tools
Arm group label:
ROADmAP schema
Arm group label:
SANOS
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.
Criteria for 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.
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mexican Consulate's Ventanilla de Salud (VDS)
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Leng, MD, MPH
Email:
lengj@mskcc.org
Start date:
December 22, 2022
Completion date:
August 11, 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05770570
http://www.mskcc.org
