Physical ActivityNCT03059901
Caminamos: A Smartphone App to Connect With Walking Partners
A study testing Caminamos App in people with Physical Activity, run by Klein Buendel, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Caminamos App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Klein Buendel, Inc.
Golden, Colorado, 80401
Stanford University, School of Medicine, The Stanford Prevention Research Center
Palo Alto, California, 94304-8445
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Caminamos App
- Keywords
- Physical Activity, Latina Women, Minority Health, Mobile Technology, Social Support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caminamos AppOther
Mobile phone that encourages Latina women to walk together through social support.
| Study group | Role | What they receive |
|---|---|---|
| More App Notifications | Experimental | Participants receive more notifications than the Active Comparator group from the Caminamos app to walk. Receives: Other: Caminamos App |
| Normal App Notifications | Active comparator | Participants receive less notifications than the Experimental group from the Caminamos app to walk. Receives: Other: Caminamos App |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Questionnaire
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start4 Aug 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Valerie Myers, PhD, Principal investigator, Senior Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059901
- Sponsor's protocol ID
- R43MD009652
- Other IDs
- R43MD009652-01, 303
- Status last verified
- Aug 2018
- First submitted
- 16 Feb 2017
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jackson M. Fact sheet: the state of Latinas in the United States. Center for American Progress. http://www.americanprogress.org/issues/race/report/2013/11/07/79167/fact-sheet-the-state-of-latinas-in-the-united-states/. December 7, 2013. Accessed: July 28, 2014.
Adams PF, Kirzinger WK, Martinez ME. Summary health statistics for the u.s. Population: national health interview survey, 2011. Vital Health Stat 10. 2012 Dec;(255):1-110.
PubMed 25116371U.S.Department of Health & Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau. Women's Health USA 2011. Rockville, Maryland: U.S. Department of Health and Human Services; 2011. http://www.mchb.hrsa.gov/whusa11/hstat/hshb/pages/201pa.html
Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
PubMed 16534088Fisher KJ, Li F. A community-based walking trial to improve neighborhood quality of life in older adults: a multilevel analysis. Ann Behav Med. 2004 Dec;28(3):186-94. doi: 10.1207/s15324796abm2803_7.
PubMed 15576257Lee RE, Goldberg JH, Sallis JF, Hickmann SA, Castro CM, Chen AH. A prospective analysis of the relationship between walking and mood in sedentary ethnic minority women. Women Health. 2001;32(4):1-15. doi: 10.1300/J013v32n04_01.
PubMed 11548133Centers for Disease Control and Prevention. Physical activity and health. CDC Web site. http://www.cdc.gov/physicalactivity/everyone/health/. Accessed: July 28, 2014.
Brown DW, Balluz LS, Heath GW, Moriarty DG, Ford ES, Giles WH, Mokdad AH. Associations between recommended levels of physical activity and health-related quality of life. Findings from the 2001 Behavioral Risk Factor Surveillance System (BRFSS) survey. Prev Med. 2003 Nov;37(5):520-8. doi: 10.1016/s0091-7435(03)00179-8.
PubMed 14572437Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
PubMed 17785709Wilcox S, Bopp M, Oberrecht L, Kammermann SK, McElmurray CT. Psychosocial and perceived environmental correlates of physical activity in rural and older african american and white women. J Gerontol B Psychol Sci Soc Sci. 2003 Nov;58(6):P329-37. doi: 10.1093/geronb/58.6.p329.
PubMed 14614117Conn VS, Phillips LJ, Ruppar TM, Chase JA. Physical activity interventions with healthy minority adults: meta-analysis of behavior and health outcomes. J Health Care Poor Underserved. 2012 Feb;23(1):59-80. doi: 10.1353/hpu.2012.0032.
PubMed 22643462Juarbe T, Turok XP, Perez-Stable EJ. Perceived benefits and barriers to physical activity among older Latina women. West J Nurs Res. 2002 Dec;24(8):868-86. doi: 10.1177/019394502237699.
PubMed 12469724Ickes MJ, Sharma M. A systematic review of physical activity interventions in Hispanic adults. J Environ Public Health. 2012;2012:156435. doi: 10.1155/2012/156435. Epub 2012 Feb 8.
PubMed 22496702Lopez MH, Gonzalez-Barrera A, Patten E. Closing the digital divide : Latinos and technology adoption. Pew Research Center, Pew Hispanic Center. http://www.pewhispanic.org/files/2013/03/Latinos_Social_Media_and_Mobile_Tech_03-2013_final.pdf. March 7, 2013. Accessed: July 14, 2014.
Zickuhr K. Three-quarters of smartphone owners use location-based services. Pew Internet & American Life Project. http://www.pewinternet.org/files/old-media/Files/Reports/2012/PIP_Location_based_services_2012_Report.pdf. May 11, 2012. Accessed: July 14, 2014.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caminamos: A Location-based Smartphone App for Latinas to Connect With Nearby Walking Partners
- ClinicalTrials.gov ID
- NCT03059901
- Acronym / sponsor ID
- R43MD009652
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Latina Women, Minority Health, Mobile Technology, Social Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 4 Aug 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 20 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| More App Notifications | Experimental | Other: Caminamos AppParticipants receive more notifications than the Active Comparator group from the Caminamos app to walk. |
| Normal App Notifications | Active comparator | Other: Caminamos AppParticipants receive less notifications than the Experimental group from the Caminamos app to walk. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caminamos AppMobile phone that encourages Latina women to walk together through social support. | Other | More App Notifications, Normal App Notifications |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundJackson M. Fact sheet: the state of Latinas in the United States. Center for American Progress. http://www.americanprogress.org/issues/race/report/2013/11/07/79167/fact-sheet-the-state-of-latinas-in-the-united-states/. December 7, 2013. Accessed: July 28, 2014.
- Background: PubMed 25116371Adams PF, Kirzinger WK, Martinez ME. Summary health statistics for the u.s. Population: national health interview survey, 2011. Vital Health Stat 10. 2012 Dec;(255):1-110.
- BackgroundU.S.Department of Health & Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau. Women's Health USA 2011. Rockville, Maryland: U.S. Department of Health and Human Services; 2011. http://www.mchb.hrsa.gov/whusa11/hstat/hshb/pages/201pa.html
- Background: PubMed 16534088Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
- Background: PubMed 15576257Fisher KJ, Li F. A community-based walking trial to improve neighborhood quality of life in older adults: a multilevel analysis. Ann Behav Med. 2004 Dec;28(3):186-94. doi: 10.1207/s15324796abm2803_7.
- Background: PubMed 11548133Lee RE, Goldberg JH, Sallis JF, Hickmann SA, Castro CM, Chen AH. A prospective analysis of the relationship between walking and mood in sedentary ethnic minority women. Women Health. 2001;32(4):1-15. doi: 10.1300/J013v32n04_01.
- BackgroundCenters for Disease Control and Prevention. Physical activity and health. CDC Web site. http://www.cdc.gov/physicalactivity/everyone/health/. Accessed: July 28, 2014.
- Background: PubMed 14572437Brown DW, Balluz LS, Heath GW, Moriarty DG, Ford ES, Giles WH, Mokdad AH. Associations between recommended levels of physical activity and health-related quality of life. Findings from the 2001 Behavioral Risk Factor Surveillance System (BRFSS) survey. Prev Med. 2003 Nov;37(5):520-8. doi: 10.1016/s0091-7435(03)00179-8.
- Background: PubMed 17785709Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
- Background: PubMed 14614117Wilcox S, Bopp M, Oberrecht L, Kammermann SK, McElmurray CT. Psychosocial and perceived environmental correlates of physical activity in rural and older african american and white women. J Gerontol B Psychol Sci Soc Sci. 2003 Nov;58(6):P329-37. doi: 10.1093/geronb/58.6.p329.
- Background: PubMed 22643462Conn VS, Phillips LJ, Ruppar TM, Chase JA. Physical activity interventions with healthy minority adults: meta-analysis of behavior and health outcomes. J Health Care Poor Underserved. 2012 Feb;23(1):59-80. doi: 10.1353/hpu.2012.0032.
- Background: PubMed 12469724Juarbe T, Turok XP, Perez-Stable EJ. Perceived benefits and barriers to physical activity among older Latina women. West J Nurs Res. 2002 Dec;24(8):868-86. doi: 10.1177/019394502237699.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Myers, PhD principal investigator
Senior Scientist
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caminamos App in people with Physical Activity, run by Klein Buendel, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059901, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.