Trial Outcomes & Findings for The VA-STRIDE Study (NCT NCT00731094)
NCT ID: NCT00731094
Last Updated: 2015-04-27
Results Overview
Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire
COMPLETED
NA
232 participants
Month 0
2015-04-27
Participant Flow
Participant milestones
| Measure |
Physcial Activity Intervention
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
116
|
|
Overall Study
Month 6
|
101
|
107
|
|
Overall Study
COMPLETED
|
98
|
105
|
|
Overall Study
NOT COMPLETED
|
18
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The VA-STRIDE Study
Baseline characteristics by cohort
| Measure |
Physcial Activity Intervention
n=116 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
116 participants
n=7 Participants
|
232 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.1 kg/m2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
32.2 kg/m2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
31.6 kg/m2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 0Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire
Outcome measures
| Measure |
Physical Activity Intervention
n=116 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
|
37 participants
|
44 participants
|
PRIMARY outcome
Timeframe: Month 6Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire
Outcome measures
| Measure |
Physical Activity Intervention
n=101 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=106 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire
|
48 participants
|
53 participants
|
PRIMARY outcome
Timeframe: Month 12Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire
Outcome measures
| Measure |
Physical Activity Intervention
n=97 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=105 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire
|
52 participants
|
49 participants
|
PRIMARY outcome
Timeframe: Month 0Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=97 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=103 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Moderate Intensity Physical Activity: Accelerometer
|
31 participants
|
36 participants
|
PRIMARY outcome
Timeframe: Month 6Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=77 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=76 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Moderate Intensity Physical Activity: Accelerometer
|
26 participants
|
19 participants
|
PRIMARY outcome
Timeframe: Month 12Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=71 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=74 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Moderate Intensity Physical Activity: Accelerometer
|
24 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Month 0Weight in kilograms (kg) measured at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=116 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Weight
|
95.5 kg
Standard Deviation 16.9
|
98.7 kg
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Month 6Weight in kilograms at measured at Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=101 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=106 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Weight
|
95.2 kg
Standard Deviation 17.5
|
97.7 kg
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Month 12Weight in kilograms measured at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=98 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=104 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Weight
|
95.3 kg
Standard Deviation 17.5
|
98.0 kg
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Month 0Systolic BP in millimeters of mercury (mmHg) measured at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=116 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Systolic Blood Pressure (BP)
|
126.1 mmHg
Standard Deviation 17.8
|
126.1 mmHg
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Month 6Systolic BP measured at Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=97 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=104 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Systolic BP
|
129.1 mmHg
Standard Deviation 17.8
|
130.1 mmHg
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: Month 12Systolic BP measured at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=98 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=101 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Systolic BP
|
130.0 mmHg
Standard Deviation 18.3
|
129.3 mmHg
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: Month 0Diastolic BP measured at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=116 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Diastolic BP
|
73.1 mmHg
Standard Deviation 9.7
|
74.1 mmHg
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Month 6Diastolic BP measured at Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=97 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=104 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Diastolic BP
|
73.7 mmHg
Standard Deviation 10.8
|
75.7 mmHg
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Month 12Diastolic BP measured at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=98 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=101 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Diastolic BP
|
74.4 mmHg
Standard Deviation 10.3
|
75.9 mmHg
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: Month 0LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=95 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=108 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Low-density Lipoprotein (LDL) Cholesterol
|
95.3 mg/dL
Standard Deviation 33.7
|
96.4 mg/dL
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: Month 6LDL cholesterol measured at Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=77 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=75 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
LDL Cholesterol
|
91.6 mg/dL
Standard Deviation 33.4
|
95.8 mg/dL
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: Month 12LDL cholesterol measured at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=49 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=50 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
LDL Cholesterol
|
92.4 mg/dL
Standard Deviation 31.9
|
96.8 mg/dL
Standard Deviation 39.2
|
SECONDARY outcome
Timeframe: Month 0HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=95 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=108 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
High-density Lipoprotein (HDL) Cholesterol
|
45.4 mg/dL
Standard Deviation 12.6
|
43.2 mg/dL
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Month 6HDL cholesterol measured at Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=77 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=75 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
HDL Cholesterol
|
46.0 mg/dL
Standard Deviation 12.9
|
44.4 mg/dL
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Month 12HDL cholesterol measured at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=49 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=50 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
HDL Cholesterol
|
45.8 mg/dL
Standard Deviation 13.4
|
44.3 mg/dL
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Month 0Triglycerides measured at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=95 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=105 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Triglycerides
|
132.9 mg/dL
Standard Deviation 73.6
|
134.4 mg/dL
Standard Deviation 87.4
|
SECONDARY outcome
Timeframe: Month 6Triglycerides measured at Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=77 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=75 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Triglycerides
|
128.5 mg/dL
Standard Deviation 73.5
|
139.7 mg/dL
Standard Deviation 88.1
|
SECONDARY outcome
Timeframe: Month 12Triglycerides measured at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=49 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=50 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Triglycerides
|
145.8 mg/dL
Standard Deviation 81.8
|
144.2 mg/dL
Standard Deviation 95.4
|
SECONDARY outcome
Timeframe: Month 0HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.
Outcome measures
| Measure |
Physical Activity Intervention
n=115 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)
|
44.7 scores on a scale
Standard Deviation 8.3
|
47.0 scores on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Month 6HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.
Outcome measures
| Measure |
Physical Activity Intervention
n=101 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=106 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
HRQL: SF-36 PCS
|
45.4 scores on a scale
Standard Deviation 8.1
|
45.4 scores on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Month 12HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.
Outcome measures
| Measure |
Physical Activity Intervention
n=98 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=104 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
HRQL: SF-36 PCS
|
44.9 scores on a scale
Standard Deviation 9.3
|
45.1 scores on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Month 0HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.
Outcome measures
| Measure |
Physical Activity Intervention
n=115 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
HRQL: SF-36 Mental Component Summary Measure (MSC)
|
51.6 scores on a scale
Standard Deviation 9.6
|
53.0 scores on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Month 6HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.
Outcome measures
| Measure |
Physical Activity Intervention
n=101 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=107 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
HRQL: SF-36 MCS
|
51.3 scores on a scale
Standard Deviation 10.8
|
51.6 scores on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Month 12HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.
Outcome measures
| Measure |
Physical Activity Intervention
n=98 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=104 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
HRQL: SF-36 MCS
|
53.0 scores on a scale
Standard Deviation 9.5
|
52.8 scores on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Month 0Physical Function: 6MWD in meters measured at Month 0
Outcome measures
| Measure |
Physical Activity Intervention
n=115 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=115 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Physical Function: 6-Minute Walking Distance (6MWD)
|
435.9 meters
Standard Deviation 88.7
|
445.5 meters
Standard Deviation 100.3
|
SECONDARY outcome
Timeframe: Month 6Physical Function: 6MWD measured at Month 6
Outcome measures
| Measure |
Physical Activity Intervention
n=87 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=92 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Physical Function: 6MWD
|
453.9 meters
Standard Deviation 79.8
|
458.5 meters
Standard Deviation 105.9
|
SECONDARY outcome
Timeframe: Month 12Physical Function: 6MWD measured at Month 12
Outcome measures
| Measure |
Physical Activity Intervention
n=88 Participants
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=85 Participants
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Physical Function: 6MWD
|
457.5 meters
Standard Deviation 81.4
|
444.9 meters
Standard Deviation 127.2
|
Adverse Events
Physical Activity Intervention
Attention Control
Serious adverse events
| Measure |
Physical Activity Intervention
n=116 participants at risk
Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
|
Attention Control
n=116 participants at risk
Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Cardiac disorders
Cardiac catheterization
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Cardiac disorders
Chest pains/pressure
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
5.2%
6/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Gastrointestinal disorders
Acid reflux/vomiting
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Gastrointestinal disorders
Colitis
|
2.6%
3/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Hepatobiliary disorders
Gallbladder problems
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Infections and infestations
Ear infection
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Injury, poisoning and procedural complications
Eye trauma
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Investigations
Sleep apnea
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
2.6%
3/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Investigations
Vertigo
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Nervous system disorders
Nerve pain
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Psychiatric disorders
Anxiety/stress
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.6%
3/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
2.6%
3/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
2.6%
3/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Fluid retention in leg
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Cataract surgery
|
2.6%
3/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Colectomy
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Hernia surgery
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Knee/ankle surgery
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Pacemaker inserted
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Prostate surgery
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Surgical and medical procedures
Shoulder surgery
|
1.7%
2/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
|
Vascular disorders
Transient ischemic attack
|
0.00%
0/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
0.86%
1/116 • Data for adverse events were collected during the 12-month follow-up period.
The systematic assessment for adverse events was conducted via monthly telephone interviews with enrolled participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Kelly Hyman Burkitt, PhD
VA Pittsburgh Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place