Clinical trial NCT04629261: Effects of Bicycle-sharing Program on Health
Official title: Effects of the Mexico City´s ECOBICI Program on Health Indicators and Physical Activity Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Keywords: Shared bicycle systems
Physical activity
Body mass index
Blood pressure
Eating habits
Commuting cycling
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial: 2 intervention groups and 1 control group.
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity not related to the bicycle sharing program
timeFrame: up to 1.5 months.
measure: Physical activity not related to the bicycle sharing program
timeFrame: up to 3 months.
measure: Physical activity of bicycle sharing program
timeFrame: up to 1.5 months.
measure: Physical activity of bicycle sharing program
timeFrame: up to 3 months.
measure: Changes in body mass index
timeFrame: up to 3 months.
measure: Changes in blood pressure
timeFrame: up to 3 months.
measure: Changes in waist circumference
timeFrame: up to 3 months.
measure: Changes in hip circumference
timeFrame: up to 3 months.
measure: Changes in mental health status
timeFrame: up to 1.5 months.
measure: Changes in mental health status
timeFrame: up to 3 months.
measure: Changes in physical health
timeFrame: up to 1.5 months.
measure: Changes in physical health.
timeFrame: up to 3 months.
measure: Changes in general health status.
timeFrame: up to 1.5 months.
measure: Changes in general health status.
timeFrame: up to 3 months.
measure: Changes quality of life
timeFrame: up to 3 months.
Secondary outcomes:
measure: Changes in dietary patterns
timeFrame: up to 1.5 months.
measure: Changes in dietary patterns
timeFrame: up to 3 months.
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Salud Pública
name: Catalina Medina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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