Trial Outcomes & Findings for Caminamos: A Smartphone App for Latinas to Connect With Walking Partners (NCT NCT03854916)

NCT ID: NCT03854916

Last Updated: 2023-07-14

Results Overview

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."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

0 weeks and 4 weeks

Results posted on

2023-07-14

Participant Flow

Participant milestones

Participant milestones
Measure
Caminemos Juntas App
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Overall Study
STARTED
38
40
Overall Study
COMPLETED
38
40
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Caminemos Juntas App
n=38 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=40 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Total
n=78 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
36 Participants
n=5 Participants
39 Participants
n=7 Participants
75 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Age, Continuous
44.26 years
n=5 Participants
43.97 years
n=7 Participants
44.05 years
n=5 Participants
Sex: Female, Male
Female
38 Participants
n=5 Participants
40 Participants
n=7 Participants
78 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
38 Participants
n=5 Participants
40 Participants
n=7 Participants
78 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
38 participants
n=5 Participants
40 participants
n=7 Participants
78 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0 weeks and 4 weeks

Population: Participants with available data at 4 weeks were analyzed for this Outcome Measure.

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."

Outcome measures

Outcome measures
Measure
Caminemos Juntas App
n=34 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=35 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Change in Physical Activity at 4 Weeks
43.21 kilocalories/kg/hour
Standard Deviation 32.87
36.76 kilocalories/kg/hour
Standard Deviation 29.93

PRIMARY outcome

Timeframe: Mean change between 0 and 8 week

Population: Participants with available data at 8 weeks were analyzed for this Outcome Measure.

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.

Outcome measures

Outcome measures
Measure
Caminemos Juntas App
n=37 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=39 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Change in Physical Activity at 8 Weeks
38.07 kilocalories/kg/hour
Standard Deviation 25.7
30.07 kilocalories/kg/hour
Standard Deviation 32.55

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants with available data at 4 weeks were analyzed for this Secondary Measure.

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.

Outcome measures

Outcome measures
Measure
Caminemos Juntas App
n=34 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=35 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Perceived Receipt of Social Support for Exercise at 4 Weeks
Family
23.41 units on a scale
Standard Deviation 10.93
21.14 units on a scale
Standard Deviation 10.09
Perceived Receipt of Social Support for Exercise at 4 Weeks
Friends
20.15 units on a scale
Standard Deviation 10.14
20.86 units on a scale
Standard Deviation 9.86

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants with available data at 8 weeks were analyzed for this Secondary Measure.

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.

Outcome measures

Outcome measures
Measure
Caminemos Juntas App
n=37 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=39 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Perceived Receipt of Social Support for Exercise at 8 Weeks
Family
20.65 units on a scale
Standard Deviation 10.48
20.82 units on a scale
Standard Deviation 9.56
Perceived Receipt of Social Support for Exercise at 8 Weeks
Friends
17.97 units on a scale
Standard Deviation 8.85
20.31 units on a scale
Standard Deviation 9.50

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants with available data at 4 weeks were analyzed for this Secondary Measure.

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.

Outcome measures

Outcome measures
Measure
Caminemos Juntas App
n=34 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=35 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Functional Health and Well-being at 4 Weeks
Mental Component
47.57 units on a scale
Standard Deviation 10.83
48.16 units on a scale
Standard Deviation 10.90
Functional Health and Well-being at 4 Weeks
Physical Component
51.33 units on a scale
Standard Deviation 7.72
50.00 units on a scale
Standard Deviation 6.49

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants with available data at 8 weeks were analyzed for this Secondary Measure.

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.

Outcome measures

Outcome measures
Measure
Caminemos Juntas App
n=37 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=39 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
Functional Health and Well-being at 8 Weeks
Physical Component
50.07 units on a scale
Standard Deviation 7.68
50.87 units on a scale
Standard Deviation 5.97
Functional Health and Well-being at 8 Weeks
Mental Component
49.95 units on a scale
Standard Deviation 10.02
49.19 units on a scale
Standard Deviation 11.01

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants with available data at 8 weeks were analyzed for this Secondary Measure.

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.

Outcome measures

Outcome measures
Measure
Caminemos Juntas App
n=37 Participants
Participants use the Caminemos app. Caminemos Juntas App: A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
World Walking App
n=39 Participants
Participants use the World of Walking App. World Walking App: A mobile app that encourages users to walk.
System Usability Scale (SUS)
60.95 score on a scale
Standard Deviation 19.68
60.13 score on a scale
Standard Deviation 22.09

Adverse Events

Caminemos Juntas App

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

World Walking App

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Buller

Klein Buendel, Inc.

Phone: 3035654321

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place