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Lifestyle Intervention for Obesity

Phase 2
Recruiting
Led By Jennifer Leng, MD, MPH
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial will use 4 evidence-based components to help taxi/FHV drivers reduce weight, improve health, and create a scalable & effective lifestyle intervention.

Who is the study for?
The Taxi ROADmAP trial is for full-time taxi and FHV drivers in NYC who are at least 21 years old, have been driving for over 6 months, speak English/French/Bengali/Spanish, own a cell phone that can get texts, and are overweight or obese. It's not for those pregnant or with chronic diseases like cancer.Check my eligibility
What is being tested?
This study tests a lifestyle intervention to help taxi/FHV drivers lose weight using text messages, self-monitoring tools, phone calls, and counseling based on Social Cognitive Theory. The effectiveness-implementation hybrid design aims to optimize diet and physical activity.See study design
What are the potential side effects?
Since the interventions involve behavior change rather than medication, side effects may include discomfort from lifestyle adjustments such as changes in diet or increased physical activity levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in participant body weight from baseline to 12 months
Estimate the cost and incremental cost-effectiveness of the obesity intervention components
Feasibility of weight loss intervention for participants measured by the ROAmAP Process Evaluation Questionnaire

Trial Design

3Treatment groups
Experimental Treatment
Group I: SANOSExperimental Treatment1 Intervention
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).
Group II: ROADmAP schemaExperimental Treatment4 Interventions
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).
Group III: Consumo de Opciones Mas Ideales De Alimento (COMIDA)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Self-monitoring tools
2016
N/A
~60
Phone calls
2009
Completed Phase 4
~160
Text Messages
2011
Completed Phase 3
~8910
Counseling
2017
Completed Phase 4
~1970

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
587,831 Total Patients Enrolled
1 Trials studying Obesity
1,067 Patients Enrolled for Obesity
Jennifer Leng, MD, MPHPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
1,289 Total Patients Enrolled
1 Trials studying Obesity
1,067 Patients Enrolled for Obesity

Media Library

Counseling Clinical Trial Eligibility Overview. Trial Name: NCT05770570 — Phase 2
Obesity Research Study Groups: SANOS, ROADmAP schema, Consumo de Opciones Mas Ideales De Alimento (COMIDA)
Obesity Clinical Trial 2023: Counseling Highlights & Side Effects. Trial Name: NCT05770570 — Phase 2
Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05770570 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining spots available for participants in this research?

"Affirmative. According to the clinical trials database, this medical research is currently accepting applicants. Initially posted on December 22nd 2022 and last updated March 20th 2023, it requires 1067 participants from a single site."

Answered by AI

What is the population size for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research is actively enrolling participants starting from December 22nd 2022 and was recently updated on March 20th 20323. The team are hoping to recruit 1067 subjects across a single medical centre."

Answered by AI

What risks might patients face if they adhere to the ROADmAP schema?

"ROADmAP schema has been assessed as having a level of safety that corresponds to 2 on our 3-tier scale, given its Phase 2 status. This implies the presence of evidence corroborating its security but none vouching for its effectiveness."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Mexican Consulate's Ventanilla de Salud (VDS)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I am open to getting help for this issue that can possibly treat others as well.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)
2022. "Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05770570.
All > Overweight
~593 spots leftby Jan 2026
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