Physical ActivityCaminemosNCT03854916
Caminamos: A Smartphone App for Latinas to Connect With Walking Partners
A study testing Caminemos Juntas App and World Walking 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 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Caminemos Juntas App and World Walking App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2019to 30 Apr 2022
- 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 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Klein Buendel, Inc.
Golden, Colorado, 80401
Stanford University
Stanford, California, 94305-5405
About this study
Official title: 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.
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. 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.
- Conditions
- Physical Activity
- Being tested
- Caminemos Juntas App, World Walking App
- Keywords
- Physical Activity, Latina, Hispanic, Women, Minority Health, Mobile Technology, Social Support, mHealth, Location-based Services, Walking
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caminemos Juntas AppOther
A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking AppOther
A mobile app that encourages users to walk.
| Study group | Role | What they receive |
|---|---|---|
| Caminemos Juntas App | Experimental | Participants use the Caminemos app. Receives: Other: Caminemos Juntas App |
| World Walking App | Active comparator | Participants use the World of Walking App. Receives: Other: World Walking App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity at 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."
Measured: 0 weeks and 4 weeks
Change in Physical Activity at 8 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. 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.
Measured: Mean change between 0 and 8 week
Secondary outcomes (5)
Perceived Receipt of Social Support for Exercise at 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.
Measured: 4 weeks
Perceived Receipt of Social Support for Exercise at 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.
Measured: 8 weeks
Functional Health and Well-being at 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.
Measured: 4 weeks
Functional Health and Well-being at 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.
Measured: 8 weeks
System Usability Scale (SUS)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start28 Feb 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Stanford University
- Responsible party
- Sponsor
- Investigators
- Valerie Myers, PhD, Principal investigator, Senior Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854916
- Sponsor's protocol ID
- 0321
- Other IDs
- R44MD009652-02
- Acronym
- Caminemos
- Status last verified
- Jun 2023
- First submitted
- 11 Dec 2018
- Last updated
- 14 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. 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 Ph II
- ClinicalTrials.gov ID
- NCT03854916
- Acronym / sponsor ID
- Caminemos / 0321
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Latina, Hispanic, Women, Minority Health, Mobile Technology, Social Support, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Stanford University
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Posted 14 Jul 2023
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, ¡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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caminemos Juntas App | Experimental | Other: Caminemos Juntas AppParticipants use the Caminemos app. |
| World Walking App | Active comparator | Other: World Walking AppParticipants use the World of Walking App. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Caminemos Juntas AppA tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services. | Other | Caminemos Juntas App |
| World Walking AppA mobile app that encourages users to walk. | Other | World Walking App |
Primary outcome
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."
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.
5 secondary outcomes
Perceived Receipt of Social Support for Exercise at 4 Weeks
Time frame: 4 weeks
Perceived Receipt of Social Support for Exercise at 8 Weeks
Time frame: 8 weeks
Functional Health and Well-being at 4 Weeks
Time frame: 4 weeks
Functional Health and Well-being at 8 Weeks
Time frame: 8 weeks
System Usability Scale (SUS)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Caminemos Juntas App and World Walking 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 1 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 14 Jul 2023. 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 14 Jul 2023). 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?
Change in Physical Activity at 4 Weeks (time frame: 0 weeks and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.