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CompletedNCT00731094Updated Apr 27, 2015Results posted

The VA-STRIDE Study

An interventional study of Expert system-based physical activity counseling in Overweight, Obesity and Sedentary Lifestyle, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-27.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study was to examine the effectiveness of an expert-system, print-based physical activity (PA) intervention delivered to Veterans receiving primary care at the VA Pittsburgh Healthcare System (VAPHS).

Read the detailed description

A.1 The primary aim of the study was to determine the effect of a physical activity intervention designed to increase physical activity for sedentary Veterans at VAPHS.

A.2. Secondary aims were to assess key health-related outcomes related to the intervention including health and quality of life. The specific outcomes were to (a) estimate the impact of the intervention on physical function, health-related quality of life (HRQL), weight, blood pressure, and serum lipids; and (b) characterize variation in intervention effectiveness by participant sociodemographic and health characteristics, such as age, race, and baseline health status.

232 Veterans were randomized to either the physical activity intervention group or the attention control group. Participants randomized to the physical activity intervention group participated in an individualized physical activity counseling session at baseline, conducted by an exercise physiologist, with guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity. An additional 14 intervention counseling contacts, generated by participants' responses to physical activity questionnaires and individually tailored computer-generated expert system feedback messages based on stages of the motivational readiness for change model, were conducted via postal mail over the subsequent 12 months in parallel with routine primary care. Newsletters providing additional support and suggestions for increasing physical activity were also part of the mailed counseling contacts. Participants randomized to the attention control group participated in a generalized healthy lifestyle counseling session at baseline, conducted by a health educator, which included limited advice to become more physically active. Fourteen follow-up wellness newsletters that focused on healthy lifestyle issues other than physical activity were sent to participants via postal mail over the subsequent 12 months with the same frequency of contact as for the physical activity intervention group and in parallel with routine primary care. Assessment of effectiveness occurred at baseline, 6, and 12 months.

02

Conditions studied

  • Overweight
  • Obesity
  • Sedentary Lifestyle

Browse trials for

Keywords

  • overweight
  • sedentary lifestyle
  • exercise
  • primary health care
  • controlled clinical trials, randomized
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 232 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • at least 18 years of age at the time of enrollment,
  • one or more primary care clinic visits at VAPHS in the 12 months prior to enrollment
  • overweight or obese, with a BMI > =25.0 kg/m\^2 at the most recent primary care visit prior to enrollment.

Exclusion criteria

Exclusion Criteria:

  • primary care provider judgment that unsupervised moderate-intensity exercise will place the Veteran at risk of a cardiovascular event, or other safety concern for guided but unsupervised physical activity
  • Veteran is nonambulatory or requires assistive devices to ambulate (e.g., wheelchairs, prosthetic legs, canes or walkers),
  • Veteran regularly participates in moderate to brisk physical activity 60 minutes or more each week
  • current diagnosis of pulmonary hypertension, chronic obstructive pulmonary disease (COPD), and other comorbid conditions deemed to be contraindications for guided, unsupervised physical activity
  • self-reported blindness and/or unable to read printed material in English (e.g., a newspaper)
  • plans to move from the VAPHS treatment area in the next 12 months
  • unable or unwilling to travel to the study site 4 times during the 12-month study period
  • VAPHS employee
  • current participant in another interventional research study that may confound outcomes
  • unable or unwilling to provide signed, informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
232 participants (actual)

Study arms

  • Experimental
    Physical Activity Intervention

    Expert system-based physical activity counseling: 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

    Behavioral: Expert system-based physical activity counseling

  • No intervention
    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

Interventions

  • BehavioralExpert system-based physical activity counseling

    The intervention included 14 mailings to participants that involved completion of physical activity questionnaires printed on forms that were scanned into a computerized expert system program to generate individually-tailored feedback messages and related manuals based on the Stages of Motivational Readiness for Change Model. Newsletters providing additional support and suggestions for increasing physical activity were also part of the mailing program.

06

What researchers measure

Primary outcomes

  1. Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire

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

    Time frame: Month 0

  2. Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire

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

    Time frame: Month 6

  3. Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire

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

    Time frame: Month 12

  4. Moderate Intensity Physical Activity: Accelerometer

    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

    Time frame: Month 0

  5. Moderate Intensity Physical Activity: Accelerometer

    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

    Time frame: Month 6

  6. Moderate Intensity Physical Activity: Accelerometer

    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

    Time frame: Month 12

Secondary outcomes

  1. Weight

    Weight in kilograms (kg) measured at Month 0

    Time frame: Month 0

  2. Weight

    Weight in kilograms at measured at Month 6

    Time frame: Month 6

  3. Weight

    Weight in kilograms measured at Month 12

    Time frame: Month 12

  4. Systolic Blood Pressure (BP)

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

    Time frame: Month 0

  5. Systolic BP

    Systolic BP measured at Month 6

    Time frame: Month 6

  6. Systolic BP

    Systolic BP measured at Month 12

    Time frame: Month 12

  7. Diastolic BP

    Diastolic BP measured at Month 0

    Time frame: Month 0

  8. Diastolic BP

    Diastolic BP measured at Month 6

    Time frame: Month 6

  9. Diastolic BP

    Diastolic BP measured at Month 12

    Time frame: Month 12

  10. Low-density Lipoprotein (LDL) Cholesterol

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

    Time frame: Month 0

  11. LDL Cholesterol

    LDL cholesterol measured at Month 6

    Time frame: Month 6

  12. LDL Cholesterol

    LDL cholesterol measured at Month 12

    Time frame: Month 12

  13. High-density Lipoprotein (HDL) Cholesterol

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

    Time frame: Month 0

  14. HDL Cholesterol

    HDL cholesterol measured at Month 6

    Time frame: Month 6

  15. HDL Cholesterol

    HDL cholesterol measured at Month 12

    Time frame: Month 12

  16. Triglycerides

    Triglycerides measured at Month 0

    Time frame: Month 0

  17. Triglycerides

    Triglycerides measured at Month 6

    Time frame: Month 6

  18. Triglycerides

    Triglycerides measured at Month 12

    Time frame: Month 12

  19. Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)

    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.

    Time frame: Month 0

  20. HRQL: SF-36 PCS

    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.

    Time frame: Month 6

  21. HRQL: SF-36 PCS

    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.

    Time frame: Month 12

  22. HRQL: SF-36 Mental Component Summary Measure (MSC)

    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.

    Time frame: Month 0

  23. HRQL: SF-36 MCS

    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.

    Time frame: Month 6

  24. HRQL: SF-36 MCS

    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.

    Time frame: Month 12

  25. Physical Function: 6-Minute Walking Distance (6MWD)

    Physical Function: 6MWD in meters measured at Month 0

    Time frame: Month 0

  26. Physical Function: 6MWD

    Physical Function: 6MWD measured at Month 6

    Time frame: Month 6

  27. Physical Function: 6MWD

    Physical Function: 6MWD measured at Month 12

    Time frame: Month 12

07

Results

Posted Oct 30, 2014

Participant flow

Participant flow — Overall Study
MilestonePhyscial Activity InterventionAttention Control
Started116116
Month 6101107
Completed98105
Not completed1811

Outcome measures

PrimaryModerate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire

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

Time frame:
Month 0
Reported as:
Number · participants
Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
participantsPhysical Activity InterventionAttention Control
Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire3744
PrimaryModerate Intensity Physical Activity: Modified CHAMPS Questionnaire

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

Time frame:
Month 6
Reported as:
Number · participants
Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire
participantsPhysical Activity InterventionAttention Control
Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire4853
PrimaryModerate Intensity Physical Activity: Modified CHAMPS Questionnaire

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

Time frame:
Month 12
Reported as:
Number · participants
Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire
participantsPhysical Activity InterventionAttention Control
Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire5249
PrimaryModerate Intensity Physical Activity: Accelerometer

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

Time frame:
Month 0
Reported as:
Number · participants
Moderate Intensity Physical Activity: Accelerometer
participantsPhysical Activity InterventionAttention Control
Moderate Intensity Physical Activity: Accelerometer3136
PrimaryModerate Intensity Physical Activity: Accelerometer

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

Time frame:
Month 6
Reported as:
Number · participants
Moderate Intensity Physical Activity: Accelerometer
participantsPhysical Activity InterventionAttention Control
Moderate Intensity Physical Activity: Accelerometer2619
PrimaryModerate Intensity Physical Activity: Accelerometer

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

Time frame:
Month 12
Reported as:
Number · participants
Moderate Intensity Physical Activity: Accelerometer
participantsPhysical Activity InterventionAttention Control
Moderate Intensity Physical Activity: Accelerometer2421
SecondaryWeight

Weight in kilograms (kg) measured at Month 0

Time frame:
Month 0
Reported as:
Mean · kg
Weight
kgPhysical Activity InterventionAttention Control
Weight95.5 ± 16.998.7 ± 17.3
SecondaryWeight

Weight in kilograms at measured at Month 6

Time frame:
Month 6
Reported as:
Mean · kg
Weight
kgPhysical Activity InterventionAttention Control
Weight95.2 ± 17.597.7 ± 17.7
SecondaryWeight

Weight in kilograms measured at Month 12

Time frame:
Month 12
Reported as:
Mean · kg
Weight
kgPhysical Activity InterventionAttention Control
Weight95.3 ± 17.598.0 ± 17.4
SecondarySystolic Blood Pressure (BP)

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

Time frame:
Month 0
Reported as:
Mean · mmHg
Systolic Blood Pressure (BP)
mmHgPhysical Activity InterventionAttention Control
Systolic Blood Pressure (BP)126.1 ± 17.8126.1 ± 14.2
SecondarySystolic BP

Systolic BP measured at Month 6

Time frame:
Month 6
Reported as:
Mean · mmHg
Systolic BP
mmHgPhysical Activity InterventionAttention Control
Systolic BP129.1 ± 17.8130.1 ± 16.0
SecondarySystolic BP

Systolic BP measured at Month 12

Time frame:
Month 12
Reported as:
Mean · mmHg
Systolic BP
mmHgPhysical Activity InterventionAttention Control
Systolic BP130.0 ± 18.3129.3 ± 16.9
SecondaryDiastolic BP

Diastolic BP measured at Month 0

Time frame:
Month 0
Reported as:
Mean · mmHg
Diastolic BP
mmHgPhysical Activity InterventionAttention Control
Diastolic BP73.1 ± 9.774.1 ± 9.5
SecondaryDiastolic BP

Diastolic BP measured at Month 6

Time frame:
Month 6
Reported as:
Mean · mmHg
Diastolic BP
mmHgPhysical Activity InterventionAttention Control
Diastolic BP73.7 ± 10.875.7 ± 10.0
SecondaryDiastolic BP

Diastolic BP measured at Month 12

Time frame:
Month 12
Reported as:
Mean · mmHg
Diastolic BP
mmHgPhysical Activity InterventionAttention Control
Diastolic BP74.4 ± 10.375.9 ± 9.9
SecondaryLow-density Lipoprotein (LDL) Cholesterol

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

Time frame:
Month 0
Reported as:
Mean · mg/dL
Low-density Lipoprotein (LDL) Cholesterol
mg/dLPhysical Activity InterventionAttention Control
Low-density Lipoprotein (LDL) Cholesterol95.3 ± 33.796.4 ± 33.1
SecondaryLDL Cholesterol

LDL cholesterol measured at Month 6

Time frame:
Month 6
Reported as:
Mean · mg/dL
LDL Cholesterol
mg/dLPhysical Activity InterventionAttention Control
LDL Cholesterol91.6 ± 33.495.8 ± 29.3
SecondaryLDL Cholesterol

LDL cholesterol measured at Month 12

Time frame:
Month 12
Reported as:
Mean · mg/dL
LDL Cholesterol
mg/dLPhysical Activity InterventionAttention Control
LDL Cholesterol92.4 ± 31.996.8 ± 39.2
SecondaryHigh-density Lipoprotein (HDL) Cholesterol

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

Time frame:
Month 0
Reported as:
Mean · mg/dL
High-density Lipoprotein (HDL) Cholesterol
mg/dLPhysical Activity InterventionAttention Control
High-density Lipoprotein (HDL) Cholesterol45.4 ± 12.643.2 ± 11.1
SecondaryHDL Cholesterol

HDL cholesterol measured at Month 6

Time frame:
Month 6
Reported as:
Mean · mg/dL
HDL Cholesterol
mg/dLPhysical Activity InterventionAttention Control
HDL Cholesterol46.0 ± 12.944.4 ± 10.2
SecondaryHDL Cholesterol

HDL cholesterol measured at Month 12

Time frame:
Month 12
Reported as:
Mean · mg/dL
HDL Cholesterol
mg/dLPhysical Activity InterventionAttention Control
HDL Cholesterol45.8 ± 13.444.3 ± 11.3
SecondaryTriglycerides

Triglycerides measured at Month 0

Time frame:
Month 0
Reported as:
Mean · mg/dL
Triglycerides
mg/dLPhysical Activity InterventionAttention Control
Triglycerides132.9 ± 73.6134.4 ± 87.4
SecondaryTriglycerides

Triglycerides measured at Month 6

Time frame:
Month 6
Reported as:
Mean · mg/dL
Triglycerides
mg/dLPhysical Activity InterventionAttention Control
Triglycerides128.5 ± 73.5139.7 ± 88.1
SecondaryTriglycerides

Triglycerides measured at Month 12

Time frame:
Month 12
Reported as:
Mean · mg/dL
Triglycerides
mg/dLPhysical Activity InterventionAttention Control
Triglycerides145.8 ± 81.8144.2 ± 95.4
SecondaryHealth Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)

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.

Time frame:
Month 0
Reported as:
Mean · scores on a scale
Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)
scores on a scalePhysical Activity InterventionAttention Control
Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)44.7 ± 8.347.0 ± 8.3
SecondaryHRQL: SF-36 PCS

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.

Time frame:
Month 6
Reported as:
Mean · scores on a scale
HRQL: SF-36 PCS
scores on a scalePhysical Activity InterventionAttention Control
HRQL: SF-36 PCS45.4 ± 8.145.4 ± 8.9
SecondaryHRQL: SF-36 PCS

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.

Time frame:
Month 12
Reported as:
Mean · scores on a scale
HRQL: SF-36 PCS
scores on a scalePhysical Activity InterventionAttention Control
HRQL: SF-36 PCS44.9 ± 9.345.1 ± 9.5
SecondaryHRQL: SF-36 Mental Component Summary Measure (MSC)

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.

Time frame:
Month 0
Reported as:
Mean · scores on a scale
HRQL: SF-36 Mental Component Summary Measure (MSC)
scores on a scalePhysical Activity InterventionAttention Control
HRQL: SF-36 Mental Component Summary Measure (MSC)51.6 ± 9.653.0 ± 8.6
SecondaryHRQL: SF-36 MCS

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.

Time frame:
Month 6
Reported as:
Mean · scores on a scale
HRQL: SF-36 MCS
scores on a scalePhysical Activity InterventionAttention Control
HRQL: SF-36 MCS51.3 ± 10.851.6 ± 9.4
SecondaryHRQL: SF-36 MCS

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.

Time frame:
Month 12
Reported as:
Mean · scores on a scale
HRQL: SF-36 MCS
scores on a scalePhysical Activity InterventionAttention Control
HRQL: SF-36 MCS53.0 ± 9.552.8 ± 8.4
SecondaryPhysical Function: 6-Minute Walking Distance (6MWD)

Physical Function: 6MWD in meters measured at Month 0

Time frame:
Month 0
Reported as:
Mean · meters
Physical Function: 6-Minute Walking Distance (6MWD)
metersPhysical Activity InterventionAttention Control
Physical Function: 6-Minute Walking Distance (6MWD)435.9 ± 88.7445.5 ± 100.3
SecondaryPhysical Function: 6MWD

Physical Function: 6MWD measured at Month 6

Time frame:
Month 6
Reported as:
Mean · meters
Physical Function: 6MWD
metersPhysical Activity InterventionAttention Control
Physical Function: 6MWD453.9 ± 79.8458.5 ± 105.9
SecondaryPhysical Function: 6MWD

Physical Function: 6MWD measured at Month 12

Time frame:
Month 12
Reported as:
Mean · meters
Physical Function: 6MWD
metersPhysical Activity InterventionAttention Control
Physical Function: 6MWD457.5 ± 81.4444.9 ± 127.2

Adverse events

Collected over Data for adverse events were collected during the 12-month follow-up period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Physical Activity Intervention—29/116 (25%)0/116 (0%)
Attention Control—33/116 (28.4%)0/116 (0%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventPhysical Activity InterventionAttention Control
Chest pains/pressureCardiac disorders2/1166/116
ColitisGastrointestinal disorders3/1160/116
Sleep apneaInvestigations2/1163/116
PneumoniaRespiratory, thoracic and mediastinal disorders3/1163/116
Shortness of breathRespiratory, thoracic and mediastinal disorders0/1163/116
Cataract surgerySurgical and medical procedures3/1162/116
Atrial fibrillationCardiac disorders2/1160/116
Cardiac catheterizationCardiac disorders1/1162/116
Hernia surgerySurgical and medical procedures0/1162/116
Knee/ankle surgerySurgical and medical procedures0/1162/116

Baseline characteristics

Age, Continuous
Age, Continuous(years)Physcial Activity InterventionAttention ControlTotal
Mean63.7 ± 12.562.6 ± 13.263.2 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)Physcial Activity InterventionAttention ControlTotal
Female202040
Male9696192
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Physcial Activity InterventionAttention ControlTotal
Hispanic or Latino437
Not Hispanic or Latino111113224
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Physcial Activity InterventionAttention ControlTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American282654
White8687173
More than one race123
Unknown or Not Reported112
Region of Enrollment
Region of Enrollment(participants)Physcial Activity InterventionAttention ControlTotal
United States116116232
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)Physcial Activity InterventionAttention ControlTotal
Mean31.1 ± 4.732.2 ± 5.031.6 ± 4.9
08

Study locations

1 site
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania 15240, United States
09

References and documents

Publications

  • Hawkins MS, Hough LJ, Berger MA, Mor MK, Steenkiste AR, Gao S, Stone RA, Burkitt KH, Marcus BH, Ciccolo JT, Kriska AM, Klinvex DT, Sevick MA. Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study. Trials. 2014 Jan 7;15:11. doi: 10.1186/1745-6215-15-11. PubMed 24398076 ↗
  • Gao S, Stone RA, Hough LJ, Haibach JP, Marcus BH, Ciccolo JT, Kriska AM, Burkitt KH, Steenkiste AR, Berger MA, Sevick MA. Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial. Prev Med Rep. 2015 Dec 21;3:113-20. doi: 10.1016/j.pmedr.2015.12.007. eCollection 2016 Jun. PubMed 26844197 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00731094
Lead sponsor
US Department of Veterans Affairs
Collaborators
Brown University, University of Pittsburgh
Responsible party
Sponsor
First posted
Aug 8, 2008
Start date
Jun 2010
Primary completion
Apr 2013
Completion
May 2013
Results posted
Oct 30, 2014
Last update
Apr 27, 2015

Study contacts

Mary Ann Sevick, ScD MS
principal investigator · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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