- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03854916
Caminamos: A Smartphone App for Latinas to Connect With Walking Partners (Caminemos)
June 22, 2023 updated by: Klein Buendel, Inc.
Caminamos: A Location-based Smartphone App for Latinas to Connect With Nearby Walking Partners Ph II
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
78
Phase
- 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
-
-
California
-
Stanford, California, United States, 94305-5405
- Stanford University
-
-
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
Ages Eligible for Study
18 years to 55 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- between the ages of 18 and 69 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 and 69 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.
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Caminemos Juntas App
Participants use the Caminemos 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.
|
A mobile app that encourages users to walk.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical Activity at 4 Weeks
Time Frame: 0 weeks and 4 weeks
|
The Community Healthy Activities Model Program for Seniors (CHAMPS) is a 41-item PA questionnaire that measures self-reported minutes-per-week of PA calculated as total weekly caloric expenditure for all PA.
It was developed for underactive populations and validated among older adults.
However, CHAMPS has been used with younger and racially/ethnically diverse populations; it is sensitive to change specifically in Latino and other populations including ones younger than senior age.
The CHAMPS asks about activities undertaken for exercise, daily activities that are physical in nature, and physically active recreational activities during "a typical week in the past 4 weeks."
|
0 weeks and 4 weeks
|
|
Change in Physical Activity at 8 Weeks
Time Frame: Mean change between 0 and 8 week
|
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.
Hours and minutes per week were assessed for different types of physical activity.
Using body weight and minutes of physical activity (by type), total caloric expenditure was calculated.
Data is presented as a T-score with higher values (positive) indicating more calories expended at 8 weeks compared to baseline.
Range = 2.5-145.2
kilocalories/kg/hr in the World Walking App condition; range = 6.9-120.1 kilocalories/kg/hr in the Caminemos condition.
This measure was administered at 8 weeks to measure changes in physical activity.
|
Mean change between 0 and 8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Receipt of Social Support for Exercise at 4 Weeks
Time Frame: 4 weeks
|
The Social Support for Exercise Survey is a 10-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 ("1/none, 2/rarely, 3/a few times, 4/often, 5/very often") with higher mean score indicating more support from family and friends.
Minimum mean score for the scale = 10; maximum mean score = 50.
|
4 weeks
|
|
Perceived Receipt of Social Support for Exercise at 8 Weeks
Time Frame: 8 weeks
|
The Social Support for Exercise Survey is a 10-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 ("1/none, 2/rarely, 3/a few times, 4/often, 5/very often") with higher mean score indicating more support from family and friends.
Minimum mean score for the scale = 10; maximum mean score = 50.
|
8 weeks
|
|
Functional Health and Well-being at 4 Weeks
Time Frame: 4 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.
The validated scoring for SF-12 was used; scoring is done by linear transformation with the mean score in the general US population being set to 50.
Mean scores above 50 indicate better than average self-reported health.
Range = 30.7-61.3 units in the physical component in Caminemos condition; range = 28.2-62.2
units in the physical component in the World Walking App condition.
For the mental component, range = 14.8-60.7 in Caminemos condition; range = 18.9-62.9 in the World Walking App.
Raw scores are provided.
|
4 weeks
|
|
Functional Health and Well-being at 8 Weeks
Time Frame: 8 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.
The validated scoring for SF-12 was used; scoring is done by linear transformation with the mean score in the general US population being set to 50.
Mean scores above 50 indicate better than average self-reported health.
Range = 32.0-61.6 units in the physical component in Caminemos condition; range = 32.4-59.2
units in the physical component in the World Walking App condition.
For the mental component, range = 28.0-60.8 in Caminemos condition; range = 22.3-60.8 in the World Walking App.
Raw scores are provided.
|
8 weeks
|
|
System Usability Scale (SUS)
Time Frame: 8 weeks
|
Ten likert-type questions assessing user-friendliness of technology.
Each question has five answer options that range from 1="Strongly Disagree" to 5="Strongly Agree".
Scores range from 0-100.
The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100.
A score above 68 is considered above average.
Higher scores indicate a more usable technology compared to lower.
Raw scores are presented.
Range = 20-100 for Caminemos; range = 15-95 for World Walking App.
All scores averaged.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Valerie Myers, PhD, Senior Scientist
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)
February 28, 2019
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
December 11, 2018
First Submitted That Met QC Criteria
February 25, 2019
First Posted (Actual)
February 26, 2019
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
June 22, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0321
- R44MD009652-02 (U.S. NIH Grant/Contract)
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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