Physical Activity Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | September 30, 2021 |
Est. primary completion date | April 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Salud Publica, Mexico |
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical activity not related to the bicycle sharing program | Assessed by questionnaire and expressed in minutes per week | up to 1.5 months. | |
Primary | Physical activity not related to the bicycle sharing program | Assessed by questionnaire and expressed in minutes per week | up to 3 months. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | Changes in hip circumference | Assessed by direct measurements done by trained staff and expressed in cm. | up to 3 months. | |
Primary | 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. | |
Primary | 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. | |
Primary | Changes in physical health | Assessed by questionnaire. Expressed by a percentage. | up to 1.5 months. | |
Primary | Changes in physical health. | Assessed by questionnaire. Expressed by a percentage. | up to 3 months. | |
Primary | Changes in general health status. | Assessed by questionnaire. Expressed by a percentage. | up to 1.5 months. | |
Primary | Changes in general health status. | Assessed by questionnaire. Expressed by a percentage. | up to 3 months. | |
Primary | Changes quality of life | Assessed by questionnaire. Expressed by a percentage. Good and bad | up to 3 months. | |
Secondary | Changes in dietary patterns | Assessed by a a semi-quantitative food frequency questionnaire. Expressed by a percentage. | up to 1.5 months. | |
Secondary | Changes in dietary patterns | Assessed by a a semi-quantitative food frequency questionnaire. Expressed by a percentage. | up to 3 months. |
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