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Quality of LifeTRUSTNCT03741582

Urban Transformations and Health: the Case of TransMiCable in Bogotá

An observational study of Quality of Life and Social Capital, run by University of Los Andes, Columbia at 1 site in Colombia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Quality of Life, Social Capital, Transportation
What is being tested?
TransMiCable
How many people
2,052 participants
Where
1 siteColombia
Study dates
15 Feb 2018to 1 Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Every participant of the study is an adult that lives on one of the 225 blocks selected from each buffer with probability proportional to the size of the catchment areas' population. For selecting the participant, 4 or 5 households were systematically selected on each block. The families of each household were selected with a random numbers chart, as well as the participant listing every adult by age.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Colombia1 site
  • Universidad de los Andes

    Bogotá, Bogota D.C., 11111111

Other trials in Colombia

About this study

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.

Being tested
TransMiCable
Keywords
Transportation, Urban Health, Quality of Life, Social Capital, Crime, Respiratory Diseases
Medical subject headings
Motor Activity, Respiration Disorders, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TransMiCableOther

    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.

Study groups in NCT03741582
Study groupRoleWhat they receive
Control - San Cristobal1021 individuals located in an area with no access to the intervention (TransMicable). The control area was defined by a 800-meter buffer around each projected station of the car, "San Cristobal" was an area with a projected but non financed Cable Car.
Intervention - Ciudad Bolviar1031 individuals who live in the area of influence of TransMiCable. The area of influence of TransMiCable was defined by a 800-meter radial buffer around each station of the cable car.
Receives: Other: TransMiCable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. Questionnaire survey Transport section

    Characterization of the use of public transport measured with questions taken from the Mobility Survey of Bogotá.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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).

    Measured: 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

  7. 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.

    Measured: 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

  8. 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"

    Measured: 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

  9. Questionnaire survey loneliness section

    Loneliness of the participant measured with the University of California, los Angeles (UCLA) Scale of Loneliness.

    Measured: 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

  10. 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.

    Measured: 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

  11. Environment evaluations SOPARC

    Observed levels of physical activity in the parks and recreation centers using System for Observing Play and Recreation in Communities (SOPARC).

    Measured: 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

  12. 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.

    Measured: 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

  13. Crime measurements

    A Secondary-data analysis of Crime using time trends from official surveillance systems for homicides.

    Measured: This measurements are performed by different official systems and were collected by the end of each year.

  14. Respiratory diseases measurements

    A Secondary-data analysis of Respiratory diseases using time trends from official surveillance systems for acute respiratory diseases.

    Measured: This measurements are performed by different official systems and were collected by the end of each year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start15 Feb 2018
  3. Primary completion5 Aug 2023
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,052 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03741582
Sponsor's protocol ID
806-2017
Acronym
TRUST
Status last verified
Dec 2024
First submitted
19 Oct 2018
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Social Capital, run by University of Los Andes, Columbia at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Basic activity monitoring (time frame: 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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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