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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03059901
Other study ID # R43MD009652
Secondary ID R43MD009652-0130
Status Completed
Phase N/A
First received
Last updated
Start date August 4, 2015
Est. completion date December 31, 2016

Study information

Verified date August 2018
Source Klein Buendel, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Caminamos App
Mobile phone that encourages Latina women to walk together through social support.

Locations

Country Name City State
United States Klein Buendel, Inc. Golden Colorado
United States Stanford University, School of Medicine, The Stanford Prevention Research Center Palo Alto California

Sponsors (3)

Lead Sponsor Collaborator
Klein Buendel, Inc. National Institute on Minority Health and Health Disparities (NIMHD), Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

Albright CL, Pruitt L, Castro C, Gonzalez A, Woo S, King AC. Modifying physical activity in a multiethnic sample of low-income women: one-year results from the IMPACT (Increasing Motivation for Physical ACTivity) project. Ann Behav Med. 2005 Dec;30(3):191-200. — View Citation

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. — View Citation

Centers for Disease Control and Prevention. Physical activity and health. CDC Web site. http://www.cdc.gov/physicalactivity/everyone/health/. Accessed: July 28, 2014.

Conn 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. Review. — View Citation

Fisher 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. — View Citation

Ickes 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. Review. — View Citation

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.

Juarbe T, Turok XP, Pérez-Stable EJ. Perceived benefits and barriers to physical activity among older Latina women. West J Nurs Res. 2002 Dec;24(8):868-86. — View Citation

Lee 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. — View Citation

Lopez 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.

Moadel 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. Epub 2007 Sep 4. — View Citation

Smith A. Smartphone Ownership 2013 Update. Pew Research Internet Project. http://www.pewinternet.org/2013/06/05/smartphone-ownership-2013/. 2013. Accessed: July 14, 2014.

U.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. Review. — View Citation

Wilcox 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. — View Citation

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.

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
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