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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03741582
Other study ID # 806-2017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 15, 2018
Est. completion date June 1, 2025

Study information

Verified date June 2023
Source University of Los Andes, Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cable cars are means of transportation with urban mobility benefits for vulnerable populations living in areas with geographic barriers. Despite their popularity, there is no evidence of cable cars' potential health effects. TransMicable, located in "Ciudad Bolivar", Bogota, Colombia will open in late-2018 presenting an unprecedented opportunity to assess the health impacts and accessibility improvements. The investigators aim is to assess the effect of theTransMiCable implementation on social determinants of health (social capital, employment, crime, transport, microenvironment pollution, built environment), healthy behaviors (leisure and transport physical activity) and health outcomes (health-related quality of life, respiratory diseases and homicides). The investigators are conducting a controlled quasi-experimental pre-post study with six elements: 1) The co-construction of a conceptual framework using a causal loop diagram with stakeholders of multiple sectors. 2) A (non-intervention - intervention) quantitative study of social capital, community participation, travel time, costs, demand, modal choice, physical activity and health-related quality of life using repeated in-person questionnaire, anthropometric measurements and physical activity using accelerometers. 3) A transport trajectory study in a subsample of the population of the quantitative study using a mobile application to track journeys. 4) A subsample of environment evaluations 5) Our Voice in the Neighborhood qualitative study to address the potential change in perceptions of the neighborhood using Citizen Science "by the people" involving the community and local public and private stakeholders and 6) A Secondary-data analysis of Crime and Respiratory diseases using time trends from official surveillance systems for homicides and acute respiratory diseases. The investigators' main hypothesis are 1) There is an increase in the Social Capital and Quality of life indicators in the TransMicable target area after the implementation when compared to other neighborhoods without TransMiCable. 2) There is a significant decrease in travel time and cost for trips to downtown Bogota and an increase in the total number of trips for residents of "Ciudad Bolivar" neighborhoods with TransMiCable, after the implementation of TransMiCable when compared to other neighborhoods without TransMiCable in the locality of "San Cristobal". 3) There is a significant shift in modal choice for the resident of "Ciudad Bolivar" from informal transport service to the TransMiCable system with a positive association in terms of proximity to TransMiCable stations. 4) Most TransMiCable users are former informal bus transit and formal bus feeder users. While most users will access TransMiCable by walking, some living further from stations will take informal transport services to access to TransMiCable. 5) There is a reduction in the microenvironment pollution around the target area of TransMiCable when compared to the control area. 6) There is a change in the perception of the neighborhood for residents of the target area of TransMiCable when compared to the control area. 7) There is a significant decrease in the prevalence of homicides and acute respiratory diseases in the area of the TransMiCable implementation in comparison to the control area without TransMiCable. The results of this study will allow us to understand baseline dynamics, while, in the long-term, allowing us to assess the changes in travel and health behaviors.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2052
Est. completion date June 1, 2025
Est. primary completion date May 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has minimum 18 years old - Has lived over the past 2 years in the study area - Would not move from the study area in the next 2 years - Has not any kind of cognitive problem Exclusion Criteria: - Has less than 18 years old - Has not lived over the past 2 years in the study area - Has plans to move from the study area in the next 2 years - Has any kind of cognitive problem

Study Design


Intervention

Other:
TransMiCable
TransMiCable will have one service line 3.43 km-long with four stations ("El Tunal" , "Juan Pablo II" , "Manitas" , and "Paraiso", see highlighted stops in Figure 2). "El Tunal" is the station that connects to the city's bus rapid transit system. The planned capacity of TransMiCable is 3,600 persons per hour in 163 cabins or gondolas. Each cabin fits ten passengers, with space for wheelchairs and bicycles and will be equipped with free Wi-Fi. The expected travel time reductions from each station to portal "El Tunal", through the shortest pathway, are: 26 minutes saved from "Juan Pablo II" station-from 32 to 6 minutes; 31 minutes saved from "Manitas" station-from 38 to 7 minutes and 49 minutes saved from "Paraiso" station-from 62 to 13 minutes 22. In conjunction with TransMiCable, urban projects will be implemented including the construction of parks, outdoor gyms, sport courts, community centers for children and older adults, a market, an administrative, and a tourism offices.

Locations

Country Name City State
Colombia Universidad de los Andes Bogotá

Sponsors (4)

Lead Sponsor Collaborator
University of Los Andes, Columbia Drexel University, Fundación Santa Fe de Bogota, Wellcome Trust

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Basic activity monitoring An Actigraph activity monitor is given to every participant of the study for wearing it over seven days. The reception of the monitors by the participants was prioritized in the intervention group over the control, due to the limited amount of monitors. Participants are asked to wear an ActiGraph "GT3X" or "GT3X+" accelerometer at the waist, and positioned in line with the right mid-axillary line, for at least seven consecutive days (plus an initial familiarization day and the morning of the final day) during all waking hours. Accelerometers are initialized to collect data at 60-second epochs. Participants who successfully complete the use of the monitor are included on a raffle for an special prize at the end of every measurement. In every follow-up participants will be asked to repeat the activity monitoring along with the questionnaire. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Trajectory measurement We recorded the trajectories of a subset of participants using a global positioning system (GPS) mobile application. For the first measurement, the mobile phone application Moves was installed in participants' Smart-phones to automatically record an activity diary. The application remains installed for at least seven consecutive days (plus an initial familiarization day and the morning of the final day). Data produced by the mobile application include geo-location of places visited, departures and arrival times for each place, transportation modes used classified as walking, cycling, running, and motorized transport, and depending on the Smart-phone, routes employed to access to each destination with geo-located checkpoints. Since Moves servers shut down on july 31, for the follow-up measurements will use another GPS trajectory mobile application. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Longitudinal qualitative interviews Our Voice in the Neighborhood qualitative study to address the potential change in perceptions of the neighborhood using Citizen Science "by the people" involving the community and local public and private stakeholders. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Questionnaire survey Transport section Characterization of the use of public transport measured with questions taken from the Mobility Survey of Bogotá. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Questionnaire survey IPAQ section Leisure-time physical activity spent time during a week measured with the International Physical Activity Questionnaire (IPAQ) in its long version. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Questionnaire survey Quality of life section Quality of life and wellbeing measured with the World Health Organization Quality Of Life instrument (WHOQOL-bref instrument). The instrument produces a quality of life profile with a 26-item questionnaire divided in four domains: domains: physical health, psychological, social relationships and environment. It is possible to derive a score for each one of them, which denotes the individual perception of the quality of life in each component. The score goes from 0 and increases positively until 5 for each question being 5 the best outcome possible. The mean score of each domain is used for calculating the average score, and then multiplied by 4 for making the scores comparable with WHOQOL-100 (long version of the questionnaire). First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Questionnaire survey Social capital section Social Capital measured by an adapted questionnaire based on: The World Bank (SC-IQ), The Development Bank of Latin America - CAF survey, and Encuesta Multipropósito. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Questionnaire survey Respiratory diseases section Identification of acute and chronic respiratory diseases in all the infants and elders in a household measured with a module of "less than 5" and "more than 65 years old" First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Questionnaire survey loneliness section Loneliness of the participant measured with the University of California, los Angeles (UCLA) Scale of Loneliness. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Questionnaire survey Use of free time section An inventory of activities during free time, the time participants spend going to health, educational and recreational services, and whether during the last 12 months participants attended to preventive health services. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Environment evaluations SOPARC Observed levels of physical activity in the parks and recreation centers using System for Observing Play and Recreation in Communities (SOPARC). First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Environment evaluations Air pollution personal exposure in transport microenvironments to fine particulate matter (PM2.5), equivalent black carbon (eBC), Carbon Monoxide (CO) and number of sub-micron particles (Np) using aerosol monitors, aethalometers and photoradiometers while keeping records of their time and activity while in the microenvironments. First measurement: February to December 2018, Second measurement: July 2019 to March 2020, Third measurement: March to Sep 2021, Fourth measurement: August 2022 to May 2023
Primary Crime measurements A Secondary-data analysis of Crime using time trends from official surveillance systems for homicides. This measurements are performed by different official systems and were collected by the end of each year.
Primary Respiratory diseases measurements A Secondary-data analysis of Respiratory diseases using time trends from official surveillance systems for acute respiratory diseases. This measurements are performed by different official systems and were collected by the end of each year.
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