Caminamos: A Smartphone App to Connect With Walking Partners

August 22, 2018 updated by: Klein Buendel, Inc.

Caminamos: A Location-based Smartphone App for Latinas to Connect With Nearby Walking Partners

Despite numerous interventions designed to increase physical activity, few are specifically tailored to Latinas, a population where higher rates of obesity, diabetes, and other chronic diseases are present. This proposed smartphone app will use location-based services to connect Latinas with one another in order to improve walking habits by increasing social support and decreasing perceived barriers, both of which are known to play a role in physical activity behaviors. In this Phase I research, surveys of potential end-users will determine interest in the app and focus groups will help shape a prototype of the app, which will be developed and tested to determine feasibility and functionality for a randomized Phase II intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Health disparities are high among Latinas. They are more likely to be overweight, diagnosed with diabetes, and physically inactive compared to their non-Hispanic White counterparts. Thus, interventions that target improving health access and ameliorating chronic diseases among Latinas are of high public health importance. Regular physical activity (PA) promotes physical and emotional well-being, yet PA interventions tailored for Latinas remain limited. Available data suggest that community-focused interventions produce improvements in physical activity (PA) and are well-received by Latinas especially when social and physical environments are considered (e.g., social support, safe walking areas, etc.). Research suggests that Latinos respond favorably to technological-based health interventions. Almost 90% of Latinos own a cellphone; 60% own a smartphone. Thus, health promotion interventions that can address Latinos' preferences regarding their physical and social environments while utilizing a preferred technology source (e.g., smartphone) could prove highly successful. One smartphone feature that offers great potential health promotion benefit is location-based services (LBS). LBS use geographic positioning to help users connect to their surrounding environment and to other users, thus providing them with real-time, user-specific information. This proposed project, ¡Caminamos!, will develop a smartphone app for use with 18-45 year old Latinas that uses LBS to connect women within geographically proximal neighborhoods as a way to provide social support for increased walking behaviors. Specific aims are: (1) gather input and evaluative feedback from an Expert Advisory Board (EAB) to help plan and assess the feasibility of creating the app; (2) build connections and gather input from Latino community leaders to assist in the conceptual development of the app through a Community Advisory Board (CAB); (3) conduct an online survey of a national sample of Latinas on their smartphone usage for health promotion, and interest in social networking and LBS technology features; (4) conduct iterative focus groups with Latinas age 18-45 years to guide development of app content, design, and aesthetics to fully develop a functioning prototype; and (5) conduct usability testing with Latinas to test the app's accuracy to establish users' location and connect users through the ¡Caminamos! system and users' use and satisfaction with the app. Few app-based health products are branded towards Latinas. ¡Caminamos! will address this unmet need in the marketplace. It will be the first smartphone app that uses location-based social networking to promote PA, and the only app of its kind targeted to Latinas. It will also expand upon what is known to be successful in Latino exercise engagement while simultaneously addressing key barriers to exercise. Phase I outcomes will provide the necessary framework and data for developing a full-scale app to be tested in a randomized clinical trial. In Phase III, we plan to market ¡Caminamos! directly to consumers in partnership with a company interested in expanding their brand outreach to a Latina population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-8445
        • Stanford University, School of Medicine, The Stanford Prevention Research Center
    • Colorado
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Eligibility criteria for online survey and focus groups is the ability to read and speak English or Spanish, female, consenting to inclusion in the study, self-identifying as Hispanic/Latina, and owning a smartphone.
  • Eligibility criteria for usability testing is the ability to read and speak English or Spanish, female, consenting to inclusion in the study, self-identifying as Hispanic/Latina, owning a smartphone, and willing to use the app for a four-week period.

Exclusion Criteria:

  • Exclusion criteria include being less than 18 years of age, being over 45 years of age, and being unable to speak or read English or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: More App Notifications
Participants receive more notifications than the Active Comparator group from the Caminamos app to walk.
Other: Caminamos App
Mobile phone that encourages Latina women to walk together through social support.
Active Comparator: Normal App Notifications
Participants receive less notifications than the Experimental group from the Caminamos app to walk.
Other: Caminamos App
Mobile phone that encourages Latina women to walk together through social support.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
System Usability Questionnaire
Time Frame: 4 weeks
Participant perspective of program feasibility. Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)
Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R43MD009652 (U.S. NIH Grant/Contract)
  • 303 (Klein Buendel, Inc.)
  • R43MD009652-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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