Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Counseling
BehavioralIn-person individual diet and physical activity (PA) counseling
Text Messages
BehavioralThrice-weekly diet/physical activity(PA) text messages
Phone calls
BehavioralWeekly telephone support
Self-monitoring tools
BehavioralSelf-monitoring tools
Treatment groups
1,889 Participants
are divided into 3 treatment groupsGroup A: ROADmAP schemaExperimental treatment 4 interventions
Group B: Consumo de Opciones Mas Ideales De Alimento (COMIDA)Other 1 intervention
Group C: SANOSOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12-months post-intake2
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.
Time frame
Up to 6 months3
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).
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov