NCT04629261

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 3, 2020

Last Update Submit

November 13, 2020

Conditions

Keywords

Shared bicycle systemsPhysical activityBody mass indexBlood pressureEating habitsCommuting cycling

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (2)

  • Changes in dietary patterns

    up to 1.5 months.

  • Changes in dietary patterns

    up to 3 months.

Study Arms (3)

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.

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.

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).

Interventions

Use of ECOBICI program with and without incentive.

Users with incentiveUsers with no incentive

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Interested on getting involved in the ECOBICI program.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • 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.

    PMID: 27389629BACKGROUND
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    PMID: 24626691BACKGROUND
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Related Links

MeSH Terms

Conditions

Motor ActivityFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Catalina Medina, Ph.D.

    Instituto Nacional de Salud Pública

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catalina Medina, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial: 2 intervention groups and 1 control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 16, 2020

Study Start

March 15, 2021

Primary Completion

April 15, 2021

Study Completion

September 30, 2021

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share