Trial Outcomes & Findings for Culturally and Linguistically Adapted Physical Activity Intervention for Latinas (NCT NCT02630953)
NCT ID: NCT02630953
Last Updated: 2021-03-04
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
214 participants
Primary outcome timeframe
Baseline, 6 months and 12 months
Results posted on
2021-03-04
Participant Flow
Participants attended an in-person orientation session where they received information about the study, had measures of height, weight, and self-reported PA taken to confirm eligibility. During a second visit, participants were measured (e.g, hip and waist circumference)) and given an ActiGraph GT3X+ accelerometer. After one week of continuous accelerometer wear, participants returned for their baseline visit where they completed questionnaires, had blood draws, then were randomized/
Participant milestones
| Measure |
Original Tailored Intervention
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
|---|---|---|
|
6 Month Assessment
STARTED
|
97
|
102
|
|
6 Month Assessment
COMPLETED
|
83
|
70
|
|
6 Month Assessment
NOT COMPLETED
|
14
|
32
|
|
12 Month Assessment
STARTED
|
97
|
102
|
|
12 Month Assessment
COMPLETED
|
73
|
64
|
|
12 Month Assessment
NOT COMPLETED
|
24
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Culturally and Linguistically Adapted Physical Activity Intervention for Latinas
Baseline characteristics by cohort
| Measure |
Original Tailored Intervention
n=97 Participants
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
n=102 Participants
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.14 years
STANDARD_DEVIATION 9.57 • n=93 Participants
|
43.55 years
STANDARD_DEVIATION 10.63 • n=4 Participants
|
43.80 years
STANDARD_DEVIATION 10.11 • n=27 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
97 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
44 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=93 Participants
|
102 participants
n=4 Participants
|
199 participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
30.79 kg/m^2
STANDARD_DEVIATION 5.19 • n=93 Participants
|
30.50 kg/m^2
STANDARD_DEVIATION 9.31 • n=4 Participants
|
30.64 kg/m^2
STANDARD_DEVIATION 7.56 • n=27 Participants
|
|
Self Reported Min/Week MVPA
|
10.51 minutes/week
STANDARD_DEVIATION 19.47 • n=93 Participants
|
14.33 minutes/week
STANDARD_DEVIATION 25.06 • n=4 Participants
|
12.47 minutes/week
STANDARD_DEVIATION 22.54 • n=27 Participants
|
|
Objectively Measured Min/Week MVPA
|
45.72 minutes/week
STANDARD_DEVIATION 70.93 • n=93 Participants
|
33.61 minutes/week
STANDARD_DEVIATION 71.29 • n=4 Participants
|
39.51 minutes/week
STANDARD_DEVIATION 71.20 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: Analysis was completed on the ITT sample
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.
Outcome measures
| Measure |
Original Tailored Intervention
n=97 Participants
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
n=102 Participants
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
|---|---|---|
|
Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+
Baseline
|
10 minutes/week
Interval 0.0 to 68.5
|
0 minutes/week
Interval 0.0 to 38.0
|
|
Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+
6 Months
|
36 minutes/week
Interval 0.0 to 109.75
|
28 minutes/week
Interval 0.0 to 98.5
|
|
Change in Accelerometer Measured Moderate to Vigorous PA (MVPA) by the Actigraph GT3X+
12 Months
|
36 minutes/week
Interval 0.0 to 127.0
|
40 minutes/week
Interval 0.0 to 110.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: Analysis was completed on the ITT sample
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
Outcome measures
| Measure |
Original Tailored Intervention
n=97 Participants
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
n=102 Participants
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
|---|---|---|
|
Change in Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months.
Baseline
|
0 minutes/week
Interval 0.0 to 15.0
|
0 minutes/week
Interval 0.0 to 20.0
|
|
Change in Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months.
6 Months
|
100 minutes/week
Interval 30.0 to 172.0
|
110 minutes/week
Interval 66.0 to 175.0
|
|
Change in Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months.
12 Months
|
100 minutes/week
Interval 43.5 to 183.0
|
130 minutes/week
Interval 45.0 to 195.0
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: A subset of the full sample completed biomarker analysis at baseline and 6 months
Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL), hemoglobin A1C (HbA1c), and blood pressure will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI).
Outcome measures
| Measure |
Original Tailored Intervention
n=78 Participants
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
n=75 Participants
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
|---|---|---|
|
Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)
Baseline A1c
|
5.36 percentage
Standard Deviation 0.38
|
5.43 percentage
Standard Deviation 0.83
|
|
Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL)
6 Month A1c
|
5.35 percentage
Standard Deviation 0.43
|
5.29 percentage
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: A subset of the full sample completed biomarker analysis at baseline and 6 months
Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL) will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI).
Outcome measures
| Measure |
Original Tailored Intervention
n=78 Participants
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
n=75 Participants
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
|---|---|---|
|
Changes in Cholesterol
Baseline HDL
|
51.13 mg/dL
Standard Deviation 12.54
|
52.28 mg/dL
Standard Deviation 54.13
|
|
Changes in Cholesterol
Baseline Cholesterol
|
188.65 mg/dL
Standard Deviation 31.70
|
192.00 mg/dL
Standard Deviation 37.29
|
|
Changes in Cholesterol
6 Month Cholesterol
|
188.09 mg/dL
Standard Deviation 31.17
|
185.42 mg/dL
Standard Deviation 38.42
|
|
Changes in Cholesterol
6 Month HDL
|
53.44 mg/dL
Standard Deviation 12.38
|
54.13 mg/dL
Standard Deviation 13.50
|
|
Changes in Cholesterol
Baseline LDL
|
104.80 mg/dL
Standard Deviation 26.56
|
109.75 mg/dL
Standard Deviation 30.94
|
|
Changes in Cholesterol
6 Month LDL
|
109.41 mg/dL
Standard Deviation 28.43
|
107.71 mg/dL
Standard Deviation 31.05
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: A subset of the full sample completed biomarker analysis at baseline and 6 months
Blood samples will be collected at the baseline and 6-month clinic visits.
Outcome measures
| Measure |
Original Tailored Intervention
n=78 Participants
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
n=75 Participants
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
|---|---|---|
|
Changes in Triglycerides
Baseline Triglycerides
|
166.58 mg/dL
Standard Deviation 101.60
|
149.88 mg/dL
Standard Deviation 117.94
|
|
Changes in Triglycerides
6 Month Triglycerides
|
133.91 mg/dL
Standard Deviation 90.98
|
117.94 mg/dL
Standard Deviation 57.40
|
Adverse Events
Original Tailored Intervention
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Enhanced Tailored Intervention
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Original Tailored Intervention
n=97 participants at risk
This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals).
Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
|
Enhanced Tailored Intervention
n=102 participants at risk
We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial.
Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Toe Pain
|
0.00%
0/97 • 12 months
|
0.98%
1/102 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Infected Bladder
|
0.00%
0/97 • 12 months
|
0.98%
1/102 • Number of events 1 • 12 months
|
|
General disorders
Hip Pain and Rash
|
0.00%
0/97 • 12 months
|
0.98%
1/102 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
0.00%
0/97 • 12 months
|
2.0%
2/102 • Number of events 2 • 12 months
|
|
General disorders
Heel and Back Pain
|
1.0%
1/97 • Number of events 1 • 12 months
|
0.00%
0/102 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/97 • 12 months
|
2.0%
2/102 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/97 • 12 months
|
0.98%
1/102 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
0.00%
0/97 • 12 months
|
0.98%
1/102 • Number of events 1 • 12 months
|
|
General disorders
Leg Injury
|
1.0%
1/97 • Number of events 1 • 12 months
|
0.00%
0/102 • 12 months
|
|
Reproductive system and breast disorders
Breast Biopsy
|
1.0%
1/97 • Number of events 1 • 12 months
|
0.00%
0/102 • 12 months
|
|
Cardiac disorders
Stroke (unrelated to study)
|
0.00%
0/97 • 12 months
|
0.98%
1/102 • Number of events 1 • 12 months
|
Additional Information
Dr. Bess Marcus, Principle Investigator
Brown University
Phone: 401-863-6950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place