What side effects are associated with this type of intervention?

Common treatments for obesity, particularly those involving behavior change through diet and physical activity, generally have minimal side effects. However, patients may experience initial discomfort such as muscle soreness from increased physical activity or gastrointestinal issues from dietary changes. Pharmacological treatments, such as semaglutide, can cause gastrointestinal side effects like nausea, vomiting, and diarrhea. Additionally, some psychotropic medications used in patients with severe mental illness can lead to weight gain, sedation, and anticholinergic effects, which may interfere with lifestyle interventions.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including orlistat, lorcaserin, and semaglutide. Orlistat works by inhibiting fat absorption, while lorcaserin, which was later withdrawn from the market, acted on serotonin receptors to promote satiety. Semaglutide, a GLP-1 receptor agonist, has shown significant weight loss benefits and is used in conjunction with lifestyle interventions. These pharmacological treatments are often combined with behavioral changes in diet and physical activity, similar to the interventions studied in the Taxi ROADmAP trial, which focuses on behavior change through Social Cognitive Theory.

What other types of research exist?

Promising, novel alternatives to the Taxi ROADmAP program for obesity treatment include: 1) SHED-IT community weight loss trial, which uses SCT-based tasks like goal setting, reward setting, and self-monitoring; 2) Web-Based and Mobile Delivery of an Episodic Future Thinking Intervention, which adapts episodic future thinking for family-based obesity interventions; 3) CompuLsive Exercise Activity TheraPy (LEAP), which addresses compulsive exercise in eating disorders and could be adapted for obesity treatment.

← Back to Search

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

No Placebo-Only Group

Summary

This trial tests a program called 'Taxi ROADmAP' to help taxi and for-hire vehicle drivers improve their diet and physical activity to lose weight. The program targets drivers who are often from low-income backgrounds and have higher obesity rates. It uses behavior change techniques to find the best ways to help these drivers adopt healthier habits.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Text Messages

2011

Completed Phase 3

~9000

Phone calls

2009

Completed Phase 4

~160

Counseling

2017

Completed Phase 4

~1830

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as those studied in the Taxi ROADmAP trial, focus on behavior change through diet and physical activity based on Social Cognitive Theory (SCT). SCT emphasizes observational learning, self-efficacy, and goal-setting, which help patients develop sustainable habits. These mechanisms are crucial for obesity patients as they address the root causes of weight gain, promote a caloric deficit, and lead to long-term health benefits by fostering healthier eating and activity behaviors.