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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

232 participants

Primary outcome timeframe

Month 0

Results posted on

2015-04-27

Participant Flow

Participant milestones

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

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 0

Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire

Outcome measures

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 6

Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire

Outcome measures

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 12

Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire

Outcome measures

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 0

Participants 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

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 6

Participants 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

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 12

Participants 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

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 0

Weight in kilograms (kg) measured at Month 0

Outcome measures

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 6

Weight in kilograms at measured at Month 6

Outcome measures

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 12

Weight in kilograms measured at Month 12

Outcome measures

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 0

Systolic BP in millimeters of mercury (mmHg) measured at Month 0

Outcome measures

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 6

Systolic BP measured at Month 6

Outcome measures

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 12

Systolic BP measured at Month 12

Outcome measures

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 0

Diastolic BP measured at Month 0

Outcome measures

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 6

Diastolic BP measured at Month 6

Outcome measures

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 12

Diastolic BP measured at Month 12

Outcome measures

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 0

LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0

Outcome measures

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 6

LDL cholesterol measured at Month 6

Outcome measures

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 12

LDL cholesterol measured at Month 12

Outcome measures

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 0

HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0

Outcome measures

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 6

HDL cholesterol measured at Month 6

Outcome measures

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 12

HDL cholesterol measured at Month 12

Outcome measures

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 0

Triglycerides measured at Month 0

Outcome measures

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 6

Triglycerides measured at Month 6

Outcome measures

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 12

Triglycerides measured at Month 12

Outcome measures

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 0

HRQL: 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

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 6

HRQL: 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

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 12

HRQL: 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

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 0

HRQL: 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

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 6

HRQL: 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

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 12

HRQL: 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

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 0

Physical Function: 6MWD in meters measured at Month 0

Outcome measures

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 6

Physical Function: 6MWD measured at Month 6

Outcome measures

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 12

Physical Function: 6MWD measured at Month 12

Outcome measures

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

Serious events: 29 serious events
Other events: 0 other events
Deaths: 0 deaths

Attention Control

Serious events: 33 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

Phone: 412-360-2202

Results disclosure agreements

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