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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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).
- Conditions
- Physical Activity
- 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 group | Role | What they receive |
|---|---|---|
| Users with no incentive | Experimental | Participants 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 incentive | Experimental | Participants 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-users | No intervention | Participants 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.
Physical activity not related to the bicycle sharing program
Assessed by questionnaire and expressed in minutes per week
Measured: up to 1.5 months.
Physical activity not related to the bicycle sharing program
Assessed by questionnaire and expressed in minutes per week
Measured: up to 3 months.
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.
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.
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.
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.
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.
Changes in hip circumference
Assessed by direct measurements done by trained staff and expressed in cm.
Measured: up to 3 months.
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.
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.
Changes in physical health
Assessed by questionnaire. Expressed by a percentage.
Measured: up to 1.5 months.
Changes in physical health.
Assessed by questionnaire. Expressed by a percentage.
Measured: up to 3 months.
Changes in general health status.
Assessed by questionnaire. Expressed by a percentage.
Measured: up to 1.5 months.
Changes in general health status.
Assessed by questionnaire. Expressed by a percentage.
Measured: up to 3 months.
Changes quality of life
Assessed by questionnaire. Expressed by a percentage. Good and bad
Measured: up to 3 months.
Secondary outcomes (2)
Changes in dietary patterns
Assessed by a a semi-quantitative food frequency questionnaire. Expressed by a percentage.
Measured: up to 1.5 months.
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.
- First posted16 Nov 2020
- Study start15 Mar 2021 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catalina Medina, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Catalina Medina, Ph.D., Principal investigator, Instituto Nacional de Salud Pública
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 27389629Barquera 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.
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PubMed 31530549
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Mexico City´s ECOBICI Program on Health Indicators and Physical Activity Levels
- ClinicalTrials.gov ID
- NCT04629261
- Acronym / sponsor ID
- ECOBICI and Health
- Conditions
- Physical Activity
- Keywords
- Shared bicycle systems, Physical activity, Body mass index, Blood pressure, Eating habits, Commuting cycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial: 2 intervention groups and 1 control group.
| Arm | Type | Receives |
|---|---|---|
| Users with no incentive | Experimental | Behavioral: Use of ECOBICI (public bicycle sharing program)Participants who are interested on get involved into the ECOBICI program, and who randomly will not receive a discount fee for enrollment. |
| Users with incentive | Experimental | Behavioral: Use of ECOBICI (public bicycle sharing program)Participants who are interested on get involved into the ECOBICI program, and who randomly will do receive a discount fee for enrollment. |
| Non-users | No intervention | –Participants 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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Present any physical or mental condition that inhibits cycling.
- Have participated only in phase one.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of ECOBICI (public bicycle sharing program)Use of ECOBICI program with and without incentive. | Behavioural | Users with incentive, Users with no incentive |
Primary outcome
Physical activity not related to the bicycle sharing program
Time frame: up to 1.5 months.
Assessed by questionnaire and expressed in minutes per week
Physical activity not related to the bicycle sharing program
Time frame: up to 3 months.
Assessed by questionnaire and expressed in minutes per week
Physical activity of bicycle sharing program
Time frame: up to 1.5 months.
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.
Physical activity of bicycle sharing program
Time frame: up to 3 months.
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.
Changes in body mass index
Time frame: up to 3 months.
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.
Changes in blood pressure
Time frame: up to 3 months.
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.
Changes in waist circumference
Time frame: up to 3 months.
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.
Changes in hip circumference
Time frame: up to 3 months.
Assessed by direct measurements done by trained staff and expressed in cm.
Changes in mental health status
Time frame: up to 1.5 months.
Assessed by questionnaire. Expressed by a general score. Depression if ≥9 for adults and ≥5 for older adults.
Changes in mental health status
Time frame: up to 3 months.
Assessed by questionnaire. Expressed by a general score. Depression if ≥9 for adults and ≥5 for older adults.
Changes in physical health
Time frame: up to 1.5 months.
Assessed by questionnaire. Expressed by a percentage.
Changes in physical health.
Time frame: up to 3 months.
Assessed by questionnaire. Expressed by a percentage.
Changes in general health status.
Time frame: up to 1.5 months.
Assessed by questionnaire. Expressed by a percentage.
Changes in general health status.
Time frame: up to 3 months.
Assessed by questionnaire. Expressed by a percentage.
Changes quality of life
Time frame: up to 3 months.
Assessed by questionnaire. Expressed by a percentage. Good and bad
2 secondary outcomes
Changes in dietary patterns
Time frame: up to 1.5 months.
Changes in dietary patterns
Time frame: up to 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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- Recomendaciones mundiales sobre la actividad física para la salud. Organización Mundial de la Salud. 2010.Link provided by the sponsor.
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- Jefatura del Gobierno. Gaceta Oficial Distrito Federal. Administración Pública del Distrito Federal 2014.Link provided by the sponsor.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catalina Medina, Ph.D. principal investigator
Instituto Nacional de Salud Pública
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.