Effects of Bicycle-sharing Program on Health

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Use of ECOBICI (public bicycle sharing program)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for intervention groups: Interested on getting involved in the ECOBICI program. Exclusion criteria for intervention groups: Present any physical or mental condition that inhibits cycling. Elimination criteria for intervention groups: Have participated only in phase one. Inclusion Criteria for control group: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial: 2 intervention groups and 1 control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Users with no incentive<br>Participants who are interested on get involved into the ECOBICI program, and who randomly will not receive a discount fee for enrollment. | Behavioral: Use of ECOBICI (public bicycle sharing program)<br>* Use of ECOBICI program with and without incentive.<br>|
| Experimental: Users with incentive<br>Participants who are interested on get involved into the ECOBICI program, and who randomly will do receive a discount fee for enrollment. | Behavioral: Use of ECOBICI (public bicycle sharing program)<br>* Use of ECOBICI program with and without incentive.<br>|
| No Intervention: Non-users<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity not related to the bicycle sharing program | Assessed by questionnaire and expressed in minutes per week | up to 1.5 months. | 
| Physical activity not related to the bicycle sharing program | Assessed by questionnaire and expressed in minutes per week | 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. | 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. | 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. | 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. | 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. | up to 3 months. | 
| Changes in hip circumference | Assessed by direct measurements done by trained staff and expressed in cm. | 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. | 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. | up to 3 months. | 
| Changes in physical health | Assessed by questionnaire. Expressed by a percentage. | up to 1.5 months. | 
| Changes in physical health. | Assessed by questionnaire. Expressed by a percentage. | up to 3 months. | 
| Changes in general health status. | Assessed by questionnaire. Expressed by a percentage. | up to 1.5 months. | 
| Changes in general health status. | Assessed by questionnaire. Expressed by a percentage. | up to 3 months. | 
| Changes quality of life | Assessed by questionnaire. Expressed by a percentage. Good and bad | up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dietary patterns | Assessed by a a semi-quantitative food frequency questionnaire. Expressed by a percentage. | up to 1.5 months. | 
| Changes in dietary patterns | Assessed by a a semi-quantitative food frequency questionnaire. Expressed by a percentage. | up to 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared bicycle systems, Physical activity, Body mass index, Blood pressure, Eating habits, Commuting cycling