Trial Outcomes & Findings for Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men (NCT NCT02512419)
NCT ID: NCT02512419
Last Updated: 2019-07-16
Results Overview
Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2019-07-16
Participant Flow
Participant milestones
| Measure |
Text-Enhanced Physical Activity Intervention Arm
The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals).
Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
Actigraph GT3X
|
Health Education Control Arm
The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.
Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
Actigraph GT3X
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men
Baseline characteristics by cohort
| Measure |
Text-Enhanced Physical Activity Intervention Arm
n=22 Participants
The Spanish-language Physical Activity intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals).
Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
Actigraph GT3X
|
Health Education Control Arm
n=24 Participants
The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.
Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
Actigraph GT3X
|
Total
n=46 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
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44.23 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
41.96 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
43.04 years
STANDARD_DEVIATION 10.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Objectively Measured Physical Activity
|
10 minutes/week
n=5 Participants
|
21 minutes/week
n=7 Participants
|
10.5 minutes/week
n=5 Participants
|
|
Self-Reported Physical Activity
|
10 minutes/week
n=5 Participants
|
5 minutes/week
n=7 Participants
|
10 minutes/week
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsParticipants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.
Outcome measures
| Measure |
Text-Enhanced Physical Activity Intervention Arm
n=22 Participants
The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals).
Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
Actigraph GT3X
|
Health Education Control Arm
n=24 Participants
The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.
Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
Actigraph GT3X
|
|---|---|---|
|
Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+
Baseline
|
10 minutes/week
Interval 0.0 to 42.5
|
21 minutes/week
Interval 0.0 to 59.0
|
|
Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+
6 Months
|
57.5 minutes/week
Interval 18.5 to 104.5
|
23 minutes/week
Interval 0.0 to 76.25
|
PRIMARY outcome
Timeframe: baseline and 6 monthsSelf reported physical activity (collected via 7 day PAR)
Outcome measures
| Measure |
Text-Enhanced Physical Activity Intervention Arm
n=22 Participants
The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals).
Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
Actigraph GT3X
|
Health Education Control Arm
n=24 Participants
The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.
Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
Actigraph GT3X
|
|---|---|---|
|
Self Reported Min/Week of MVPA
Baseline
|
10 min/week
Interval 0.0 to 45.0
|
5 min/week
Interval 0.0 to 43.75
|
|
Self Reported Min/Week of MVPA
6 Months
|
95 min/week
Interval 15.0 to 180.0
|
52.5 min/week
Interval 16.25 to 298.5
|
Adverse Events
Text-Enhanced Physical Activity Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education Control Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place