NCT03059901

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

August 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 20, 2018

Completed
Last Updated

September 20, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

February 16, 2017

Results QC Date

July 25, 2018

Last Update Submit

August 22, 2018

Conditions

Keywords

Physical ActivityLatina WomenMinority HealthMobile TechnologySocial Support

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

More App Notifications

EXPERIMENTAL

Participants receive more notifications than the Active Comparator group from the Caminamos app to walk.

Other: Caminamos App

Normal App Notifications

ACTIVE COMPARATOR

Participants receive less notifications than the Experimental group from the Caminamos app to walk.

Other: Caminamos App

Interventions

Mobile phone that encourages Latina women to walk together through social support.

More App NotificationsNormal App Notifications

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University, School of Medicine, The Stanford Prevention Research Center

Palo Alto, California, 94304-8445, United States

Location

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Related Publications (17)

  • 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.

    BACKGROUND
  • 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.

    PMID: 25116371BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 16534088BACKGROUND
  • 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. doi: 10.1207/s15324796abm2803_7.

    PMID: 15576257BACKGROUND
  • 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. doi: 10.1300/J013v32n04_01.

    PMID: 11548133BACKGROUND
  • Centers for Disease Control and Prevention. Physical activity and health. CDC Web site. http://www.cdc.gov/physicalactivity/everyone/health/. Accessed: July 28, 2014.

    BACKGROUND
  • 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.

    PMID: 14572437BACKGROUND
  • 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. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.

    PMID: 17785709BACKGROUND
  • 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. doi: 10.1093/geronb/58.6.p329.

    PMID: 14614117BACKGROUND
  • 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.

    PMID: 22643462BACKGROUND
  • Juarbe 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.

    PMID: 12469724BACKGROUND
  • 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.

    PMID: 22496702BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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. doi: 10.1207/s15324796abm3003_3.

    PMID: 16336070BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Valerie Myers, PhD
Organization
Klein Buendel

Study Officials

  • Valerie Myers, PhD

    Senior Scientist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

August 4, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

September 20, 2018

Results First Posted

September 20, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations