An interventional study of Caminemos Juntas App and World Walking App in Physical Activity, sponsored by Klein Buendel, Inc.. Completed at 2 sites in United States. Open to female participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Klein Buendel, Inc. · Not applicable, Interventional, and Prevention
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.
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.
Klein Buendel, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants use the Caminemos app.
Other: Caminemos Juntas App
Participants use the World of Walking App.
Other: World Walking App
A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
A mobile app that encourages users to walk.
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."
Time frame: 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.
Time frame: Mean change between 0 and 8 week
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
| Milestone | Caminemos Juntas App | World Walking App |
|---|---|---|
| Started | 38 | 40 |
| Completed | 38 | 40 |
| Not completed | 0 | 0 |
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."
| kilocalories/kg/hour | Caminemos Juntas App | World Walking App |
|---|---|---|
| Change in Physical Activity at 4 Weeks | 43.21 ± 32.87 | 36.76 ± 29.93 |
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.
| kilocalories/kg/hour | Caminemos Juntas App | World Walking App |
|---|---|---|
| Change in Physical Activity at 8 Weeks | 38.07 ± 25.7 | 30.07 ± 32.55 |
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.
| units on a scale | Caminemos Juntas App | World Walking App |
|---|---|---|
| Family | 23.41 ± 10.93 | 21.14 ± 10.09 |
| Friends | 20.15 ± 10.14 | 20.86 ± 9.86 |
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.
| units on a scale | Caminemos Juntas App | World Walking App |
|---|---|---|
| Family | 20.65 ± 10.48 | 20.82 ± 9.56 |
| Friends | 17.97 ± 8.85 | 20.31 ± 9.50 |
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.
| units on a scale | Caminemos Juntas App | World Walking App |
|---|---|---|
| Physical Component | 51.33 ± 7.72 | 50.00 ± 6.49 |
| Mental Component | 47.57 ± 10.83 | 48.16 ± 10.90 |
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.
| units on a scale | Caminemos Juntas App | World Walking App |
|---|---|---|
| Physical Component | 50.07 ± 7.68 | 50.87 ± 5.97 |
| Mental Component | 49.95 ± 10.02 | 49.19 ± 11.01 |
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.
| score on a scale | Caminemos Juntas App | World Walking App |
|---|---|---|
| System Usability Scale (SUS) | 60.95 ± 19.68 | 60.13 ± 22.09 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caminemos Juntas App | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| World Walking App | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | Caminemos Juntas App | World Walking App | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 39 | 75 |
| >=65 years | 2 | 1 | 3 |
| Age, Continuous(years) | Caminemos Juntas App | World Walking App | Total |
|---|---|---|---|
| Mean | 44.26 (18 to 67) | 43.97 (20 to 67) | 44.05 (18 to 67) |
| Sex: Female, Male(Participants) | Caminemos Juntas App | World Walking App | Total |
|---|---|---|---|
| Female | 38 | 40 | 78 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Caminemos Juntas App | World Walking App | Total |
|---|---|---|---|
| Hispanic or Latino | 38 | 40 | 78 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Caminemos Juntas App | World Walking App | Total |
|---|---|---|---|
| United States | 38 | 40 | 78 |
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Klein Buendel, Inc.