Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 195 for:    (hispanic OR latina) AND (woman OR women OR female)

Caminamos: A Smartphone App for Latinas to Connect With Walking Partners (Caminemos)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03854916
Recruitment Status : Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Stanford University
Information provided by (Responsible Party):
Klein Buendel, Inc.

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, ¡Caminemos Juntas!, 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. Through a randomized comparative-effectiveness trial, this Phase II project will test the effectiveness of a smartphone application for improving physical activity among Latinas when providing them with real-time opportunities to connect socially with the goal of walking.

Condition or disease Intervention/treatment Phase
Physical Activity Other: Caminemos Juntas App Other: World Walking App Not Applicable

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. 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. 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. In a Phase I SBIR, our team developed ¡Caminemos Juntas!, an innovative mobile phone app using Location-based Services (LBS) to connect women within geographically proximal neighborhoods as a way to provide social support for increased walking behaviors. Specifically, we (a) gathered feedback from an Expert Advisory Board (EAB) to help plan and assess the feasibility of creating the app; (b) built connections and gathered input from Latina community leaders to assist in the conceptual development of the app through a Community Advisory Board (CAB); (c) conducted 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; (d) conducted iterative focus groups with Latinas to guide development of app content, design, and aesthetics to fully develop a functioning prototype; (e) conducted field usability testing with Latinas to test the app's accuracy to establish users' location and connect users through the ¡Caminemos Juntas! system and users' use and satisfaction with the app; and (f) developed a specifications document to outline the Phase II development plan. The results of the Phase I activities provided strong support for this Phase II SBIR application. The proposed Phase II project will (1) develop a full-scale, fully programmed ¡Caminemos Juntas! app; (2) determine whether the ¡Caminemos Juntas! app can be translated and adapted to a new community environment; (3) test the performance, usage, and usability of the full-scale, fully-programmed app; and (4) evaluate whether ¡Caminemos Juntas! increases physical activity, social support for exercise, and quality of life (QOL) in Latinas. ¡Caminemos Juntas! will be evaluated in a randomized comparative-effectiveness trial (n=200) with Latinas age 18-55 in the Denver, CO and San Jose, CA areas. Overall, the proposed project has the potential to significantly impact Latinas' health by providing them with real-time opportunities to connect socially with the goal of walking. ¡Caminemos Juntas! will be the first app that use geo-location technology dedicated to walking with a social emphasis, for any population.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Caminamos: A Location-based Smartphone App for Latinas to Connect With Nearby Walking Partners Ph II
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Caminemos Juntas App
Participants use the Caminemos app.
Other: Caminemos Juntas App
A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.

Active Comparator: World Walking App
Participants use the World of Walking App.
Other: World Walking App
A mobile app that encourages users to walk.




Primary Outcome Measures :
  1. Change in Physical Activity at 6 weeks [ Time Frame: 0 weeks and 6 weeks ]
    The Community Healthy Activities Model Program for Seniors (CHAMPS) is a 41-item physical questionnaire that measures self-reported minutes-per-week of physical activity calculated as total weekly caloric expenditure in all physical activity. Each question has 6 answer options that range from "Less than 1 hour" to "9 or more hours". This measure will be administered at 0 weeks and 6 weeks to measure changes in physical activity.

  2. Change in Physical Activity at 12 weeks [ Time Frame: 6 weeks and 12 weeks ]
    The Community Healthy Activities Model Program for Seniors (CHAMPS) is a 41-item physical questionnaire that measures self-reported minutes-per-week of physical activity calculated as total weekly caloric expenditure in all physical activity. Each question has 6 answer options that range from "Less than 1 hour" to "9 or more hours". This measure will be administered at 12 weeks to measure changes in physical activity.


Secondary Outcome Measures :
  1. Change in perception of neighborhood design features related to PA at 6 weeks [ Time Frame: 0 weeks and 6 weeks ]
    The 54-item Neighborhood Environment Walkability Scale-Abbreviated (NEWS) assesses residents' perception of neighborhood design features related to PA, including residential density, land use mix, street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety,and neighborhood satisfaction. The measure is divided into 6 question families that contain a different scale likert-type scale.

  2. Change in perception of neighborhood design features related to PA at 12 weeks [ Time Frame: 12 weeks ]
    The 54-item Neighborhood Environment Walkability Scale-Abbreviated (NEWS) assesses residents' perception of neighborhood design features related to PA, including residential density, land use mix, street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety,and neighborhood satisfaction. The measure is divided into 6 question families that contain a different scale likert-type scale.

  3. Changes in perceived receipt of social support for exercise at 6 weeks [ Time Frame: 0 weeks and 6 weeks ]
    The Social Support for Exercise Survey is a 13-item self-report measure that assesses perceived receipt of social support for exercise, i.e., how often their friends or family members (separately rated) encouraged their exercise behaviors during the previous 3 month. Each question uses a likert-type scale ranging from "0/none" to "8/does not apply".

  4. Changes in perceived receipt of social support for exercise at 12 weeks [ Time Frame: 12 weeks ]
    The Social Support for Exercise Survey is a 13-item self-report measure that assesses perceived receipt of social support for exercise, i.e., how often their friends or family members (separately rated) encouraged their exercise behaviors during the previous 3 month. Each question uses a likert-type scale ranging from "0/none" to "8/does not apply".

  5. Changes in functional health and well-being at 6 weeks [ Time Frame: 0 weeks and 6 weeks ]
    The 12-Item Short Form Health Survey (SF-12) is a 12-item questionnaire that measures functional health and well-being (i.e., health-related quality of life; HRQOL). Answer scales include likert-type scales and dichotomous answer choices.

  6. Changes in functional health and well-being at 12 weeks [ Time Frame: 12 weeks ]
    The 12-Item Short Form Health Survey (SF-12) is a 12-item questionnaire that measures functional health and well-being (i.e., health-related quality of life; HRQOL). Answer scales include likert-type scales and dichotomous answer choices.

  7. Changes in neighborhood physical and social environment at 6 weeks [ Time Frame: 0 weeks and 6 weeks ]
    The Environmental Supports for Physical Activity Questionnaire - Social and Physical Environment Survey is a 27-item questionnaire that assesses neighborhood physical and social environments, i.e., neighborhood safety, access to recreation and shopping destinations, and conditions of neighborhood and facilities. Answer options use likert-type scale and dichotomous choices.

  8. Changes in neighborhood physical and social environment at 12 weeks [ Time Frame: 12 weeks ]
    The Environmental Supports for Physical Activity Questionnaire - Social and Physical Environment Survey is a 27-item questionnaire that assesses neighborhood physical and social environments, i.e., neighborhood safety, access to recreation and shopping destinations, and conditions of neighborhood and facilities. Answer options use likert-type scale and dichotomous choices.

  9. System Usability Scale (SUS) [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • between the ages of 18 and 55 years, identify as Hispanic or Latina, identify as a woman, able to read and speak either English or Spanish, own a smartphone, not pregnant, consent to participate

Exclusion Criteria:

  • Not between the ages of 18 and55 years, not identify as Hispanic or latina, not identify as a woman, unable to read or speak Spanish or English, pregnant, not own a smartphone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854916


Contacts
Layout table for location contacts
Contact: Tiffany Jerrod, MPH 3035654349 tjerrod@kleinbuendel.com
Contact: Valerie Myers, PhD 3035654343 vmyers@kleinbuendel.com

Locations
Layout table for location information
United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305-5405
Contact: Abby King, PhD    650-723-6254    king@stanford.edu   
Principal Investigator: Abby King, PhD         
United States, Colorado
Klein Buendel, Inc. Recruiting
Golden, Colorado, United States, 80401
Contact: Tiffany Jerrod, MPH    303-565-4349    tjerrod@kleinbuendel.com   
Principal Investigator: Valerie Myers, PhD         
Sponsors and Collaborators
Klein Buendel, Inc.
National Institute on Minority Health and Health Disparities (NIMHD)
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Valerie Myers, PhD Senior Scientist

Layout table for additonal information
Responsible Party: Klein Buendel, Inc.
ClinicalTrials.gov Identifier: NCT03854916     History of Changes
Other Study ID Numbers: 0321
R44MD009652-02 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Klein Buendel, Inc.:
Physical Activity
Latina
Hispanic
Women
Minority Health
Mobile Technology
Social Support
mHealth
Location-based Services
Walking