AzTrials
AzTrials

Physical ActivityNCT04629261

Effects of Bicycle-sharing Program on Health

A study testing Use of ECOBICI (public bicycle sharing program) in people with Physical Activity, run by Instituto Nacional de Salud Publica, Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the effect of the ECOBICI program in Mexico City on health indicators, activity levels, mental health, and quality of life and diet after 3 months of follow-up. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Use of ECOBICI (public bicycle sharing program)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
No sites listed yet
Study dates
15 Mar 2021to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

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 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Interested on getting involved in the ECOBICI program.
  • Participants located near by program bike-stations.
  • Age range similar to the intervention group.
  • Not enrolled in the ECOBICI program.
  • Not enrolled in an exercise program or do physical activity aimed to improve health.
  • Elimination criteria for control group:
  • Have participated only in phase one.

Who cannot join

  • Present any physical or mental condition that inhibits cycling.
  • Elimination criteria for intervention groups:
  • Have participated only in phase one.

Trial locations and contacts

No sites are listed yet.

Catalina Medina, Ph.D. contact

+5215529152920

catalina.medina@insp.mx

About this study

Official title: Effects of the Mexico City´s ECOBICI Program on Health Indicators and Physical Activity Levels

To evaluate the effect of the ECOBICI program in Mexico City on health indicators, activity levels, mental health, and quality of life and diet after 3 months of follow-up.

Read the detailed description

Non-communicable diseases (NCDs) such as obesity and type 2 diabetes mellitus (DM2) are one of the main causes of death in the world and in Mexico. According to the 2016 National Health and Nutrition Survey (ENSANUT), 9.4% has previously diagnosed diabetes and the prevalence of overweight and obesity is 71.2% in adults. Among the main risk factors for the development of these diseases are an unbalanced diet, physical inactivity and sedentarism.

According to the World Health Organization (WHO), accumulating at least 150 minutes/week of moderate-vigorous physical activity either during occupational, home, leisure time and transportation for at least 10 continuous minutes could result multiple benefits, such as the reduction of seven types of NCDs including DM2 and obesity. It has been observed that cycling, compared to other activities during leisure time, appears to be an efficient form of daily exercise and feasible to increase physical activity levels even in the most physically inactive individuals.

According to a cross-sectional study in 14 countries including the United States, it was observed that adults who commuted by bicycle had a lower risk of DM2 and obesity. Additionally, results from randomized controlled studies have shown that cycling may help reducing body fat and increase maximal oxygen consumption. However, some factors, such as the lack of attractive bike paths and the lack of safe spaces, may reduce this pattern.

The shared bicycle program has been implemented in more than 30 countries including Mexico. Among the main objectives of this program - in addition to integrating the bicycle as a form of active transportation - includes the design of a new infrastructure to offer safety and comfort to cyclists. This type of program has been evaluated in different countries. Results show that the combination of interventions, that is, the construction of bicycle facilities and the shared bicycle programs increased trips in Barcelona and Paris. In Barcelona, it was observed that this program increased the quality of life and decreased air and noise pollution. In Montreal, this program was found to attract young people and people within the highest socioeconomic status. In Valencia, Spain, it was reported that the bicycle system increased energy expenditure by 257 METs / min / week and helped reducing 2kg. of body weight in a school year. In Japan, pedaling for 30 minutes to work was found to have an effect on mental health. Finally, in the United States, it was observed that those who use active transportation to go to work have a lower probability of obesity, elevated triglyceride levels, diastolic blood pressure, and fasting glucose.

The ECOBICI program is a shared bicycle system within Mexico City. Since 2010, this program has been managed by the Ministry of Environment and the Ministry of Mobility, initially operating with 1,200 bicycles and 84 bicycle stations around Mexico City. It currently belongs to the Comprehensive Mobility Program 2018-2024, aiming at the accessibility of the population in the use of bicycles, promoting their use as an air pollution free transport. This program has been awarded within the urban public transport area, for improving air quality and for seeking a change in society.

Authorities of the ECOBICI program conducted a users' survey in 2014, this included questions related to the program and health aspects of the users. It was observed that 36% of those surveyed perceived an improvement in their physical condition, 15% reported having an improvement in their health and 8% reported having lost weight, however, to date there are few prospective studies that report the effect of the use of public bicycles on the levels of physical activity and health indicators.

Procedure The project is divided into two phases: phase 1 - initial evaluations and phase 2 - follow-up. Through social media (twitter and Facebook) adults interested on getting involved in the ECOBICI program and adults who are not involved in the program or physical activities aimed to improve their health will be invited to participate. All individuals interested on participating in this study will received an email indicating a day and time for a zoom meeting. The investigators will perform two zoom meetings, one for the intervention group and another for the control group. Within the intervention group meeting the investigators will explain them the study, benefits and risks to participate and the investigators will randomly allocate adults in intervention group 1 (free annual program fee) and intervention group 2 (annual program fee paid by participants). Within the control group meeting the investigators will explain them the study, benefits and risks to participate.

PHASE 1 (month 0). All adults who agree to participate must read and sign the consent letter before getting involved into the study. Then, the investigators will ask participants to answer a 20-minutes long questionnaire and will perform anthropometric and blood pressure measurements. All participants will be evaluated in the ECOBICI module considering COVID-19 hygiene guidelines. At the end of this phase, adults will be invited to participate in PHASE 2 of the study. If agree to participate, the investigator will ask for their cell phone number or home phone number to be contacted later.

PHASE 2 (months 1.5 and 3). The investigators will ask them if we could monitor their bicycle trajectories using the data from the Ministry of Mobility. In addition, the investigators will ask adults to use the STRAVA app (GPS app that monitors bike paths) every time they ride the bike. A manual will be send by email within instructions on how to download the application and how to use it. In addition, they will be instructed to send us by email the bike trajectories stored in the STRAVA application.

During month 1.5, the investigators will call them to conduct another survey focused on physical activity levels, diet, mental health, and health indicators (same survey that was conducted in month 0).

In month 3, the investigators will quote the patients in the ECOBICI module, within this visit a final questionnaire and anthropometric and blood pressure measurements will carry out.

All people who agree to participate in the TWO PHASES of the study will receive a voucher for $ 250 pesos ($1.25 USD).

Being tested
Use of ECOBICI (public bicycle sharing program)
Keywords
Shared bicycle systems, Physical activity, Body mass index, Blood pressure, Eating habits, Commuting cycling
Medical subject headings
Motor Activity, Feeding Behavior

What participants receive

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

  • Use of ECOBICI (public bicycle sharing program)Behavioural

    Use of ECOBICI program with and without incentive.

Study groups in NCT04629261
Study groupRoleWhat they receive
Users with no incentiveExperimentalParticipants who are interested on get involved into the ECOBICI program, and who randomly will not receive a discount fee for enrollment.
Receives: Behavioral: Use of ECOBICI (public bicycle sharing program)
Users with incentiveExperimentalParticipants who are interested on get involved into the ECOBICI program, and who randomly will do receive a discount fee for enrollment.
Receives: Behavioral: Use of ECOBICI (public bicycle sharing program)
Non-usersNo interventionParticipants with an age range similar to the intervention groups, who work or lives nearby ECOBICI's bicycle station, that are not enrolled in the ECOBICI program or in a health related program (ex. reducing weight).

What is being measured

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

  1. Physical activity not related to the bicycle sharing program

    Assessed by questionnaire and expressed in minutes per week

    Measured: up to 1.5 months.

  2. Physical activity not related to the bicycle sharing program

    Assessed by questionnaire and expressed in minutes per week

    Measured: up to 3 months.

  3. Physical activity of bicycle sharing program

    Assessed by questionnaire and daily monitoring of the users' trips through automatic system records done at bike-stations of the program and by a mobile GPS application. Expressed in kilometers per trip per day and time in minutes per trip per date.

    Measured: up to 1.5 months.

  4. Physical activity of bicycle sharing program

    Assessed by questionnaire and daily monitoring of the users' trips through automatic system records done at bike-stations of the program and by a mobile GPS application. Expressed in kilometers per trip per day and time in minutes per trip per date.

    Measured: up to 3 months.

  5. Changes in body mass index

    Assessed by direct measurements done by trained staff and expressed in kg/m^2. Classified according to the following criteria: low weight if it´s <18.5 kg/m^2, normal if it goes from 18.5 to 24.9 kg /m^2 , overweight if it goes from 25 to 29.9 kg/m^2 or obese if it´s >30 kg/m^2.

    Measured: up to 3 months.

  6. Changes in blood pressure

    Assessed by direct measurements done by trained staff and expressed in mmHg. Classified with each participant's result according to the following criteria: normotensive if the systolic blood pressure (SBP) is <140 mmHg and diastolic blood pressure (DBP) <90 mmHg or hypertensive if the SBP is ≥140 mmHg or DBP ≥90 mmHg.

    Measured: up to 3 months.

  7. Changes in waist circumference

    Assessed by direct measurements done by trained staff and expressed in cm. Classified as high if > 92 centimeters (cm) for men or > 80 cm for women.

    Measured: up to 3 months.

  8. Changes in hip circumference

    Assessed by direct measurements done by trained staff and expressed in cm.

    Measured: up to 3 months.

  9. Changes in mental health status

    Assessed by questionnaire. Expressed by a general score. Depression if ≥9 for adults and ≥5 for older adults.

    Measured: up to 1.5 months.

  10. Changes in mental health status

    Assessed by questionnaire. Expressed by a general score. Depression if ≥9 for adults and ≥5 for older adults.

    Measured: up to 3 months.

  11. Changes in physical health

    Assessed by questionnaire. Expressed by a percentage.

    Measured: up to 1.5 months.

  12. Changes in physical health.

    Assessed by questionnaire. Expressed by a percentage.

    Measured: up to 3 months.

  13. Changes in general health status.

    Assessed by questionnaire. Expressed by a percentage.

    Measured: up to 1.5 months.

  14. Changes in general health status.

    Assessed by questionnaire. Expressed by a percentage.

    Measured: up to 3 months.

  15. Changes quality of life

    Assessed by questionnaire. Expressed by a percentage. Good and bad

    Measured: up to 3 months.

Secondary outcomes (2)
  1. Changes in dietary patterns

    Assessed by a a semi-quantitative food frequency questionnaire. Expressed by a percentage.

    Measured: up to 1.5 months.

  2. Changes in dietary patterns

    Assessed by a a semi-quantitative food frequency questionnaire. Expressed by a percentage.

    Measured: up to 3 months.

Timeline

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

  1. First posted16 Nov 2020
  2. Study start15 Mar 2021 (estimated)
  3. Primary completion15 Apr 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial: 2 intervention groups and 1 control group.
Masking
Single blind
Who is masked
Participant
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04629261
Sponsor's protocol ID
ECOBICI and Health
Status last verified
Nov 2020
First submitted
3 Nov 2020
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barquera S, Pedroza-Tobias A, Medina C. Cardiovascular diseases in mega-countries: the challenges of the nutrition, physical activity and epidemiologic transitions, and the double burden of disease. Curr Opin Lipidol. 2016 Aug;27(4):329-44. doi: 10.1097/MOL.0000000000000320.

    PubMed 27389629
  • Barquera S, Campos-Nonato I, Hernandez-Barrera L, Pedroza A, Rivera-Dommarco JA. [Prevalence of obesity in Mexican adults 2000-2012]. Salud Publica Mex. 2013;55 Suppl 2:S151-60. Spanish.

    PubMed 24626691
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Questions about this trial

What is this clinical trial studying?

A study testing Use of ECOBICI (public bicycle sharing program) in people with Physical Activity, run by Instituto Nacional de Salud Publica, Mexico.

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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Catalina Medina, Ph.D. (+5215529152920, catalina.medina@insp.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity not related to the bicycle sharing program (time frame: up to 1.5 months.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04629261, which also lists 20 linked publications.

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 17 Nov 2020.

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