The VA-STRIDE Study

This study has been completed.
Sponsor:
Collaborators:
Brown University
University of Pittsburgh
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00731094
First received: August 5, 2008
Last updated: April 6, 2015
Last verified: March 2014
  Purpose

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).


Condition Intervention
Overweight
Obesity
Sedentary Lifestyle
Behavioral: Expert system-based physical activity counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Expert System-Based Feedback in Sedentary Overweight Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire

  • Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire

  • Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire

  • Moderate Intensity Physical Activity: Accelerometer [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    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

  • Moderate Intensity Physical Activity: Accelerometer [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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

  • Moderate Intensity Physical Activity: Accelerometer [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Weight [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    Weight in kilograms (kg) measured at Month 0

  • Weight [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Weight in kilograms at measured at Month 6

  • Weight [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Weight in kilograms measured at Month 12

  • Systolic Blood Pressure (BP) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    Systolic BP in millimeters of mercury (mmHg) measured at Month 0

  • Systolic BP [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Systolic BP measured at Month 6

  • Systolic BP [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Systolic BP measured at Month 12

  • Diastolic BP [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    Diastolic BP measured at Month 0

  • Diastolic BP [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Diastolic BP measured at Month 6

  • Diastolic BP [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Diastolic BP measured at Month 12

  • Low-density Lipoprotein (LDL) Cholesterol [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0

  • LDL Cholesterol [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    LDL cholesterol measured at Month 6

  • LDL Cholesterol [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    LDL cholesterol measured at Month 12

  • High-density Lipoprotein (HDL) Cholesterol [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0

  • HDL Cholesterol [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    HDL cholesterol measured at Month 6

  • HDL Cholesterol [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    HDL cholesterol measured at Month 12

  • Triglycerides [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    Triglycerides measured at Month 0

  • Triglycerides [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Triglycerides measured at Month 6

  • Triglycerides [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Triglycerides measured at Month 12

  • Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    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.

  • HRQL: SF-36 PCS [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • HRQL: SF-36 PCS [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.

  • HRQL: SF-36 Mental Component Summary Measure (MSC) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    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.

  • HRQL: SF-36 MCS [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • HRQL: SF-36 MCS [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.

  • Physical Function: 6-Minute Walking Distance (6MWD) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
    Physical Function: 6MWD in meters measured at Month 0

  • Physical Function: 6MWD [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Physical Function: 6MWD measured at Month 6

  • Physical Function: 6MWD [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Physical Function: 6MWD measured at Month 12


Enrollment: 232
Study Start Date: June 2010
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731094

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
Brown University
University of Pittsburgh
Investigators
Principal Investigator: Mary Ann Sevick, ScD MS VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00731094     History of Changes
Other Study ID Numbers: IIR 07-154
Study First Received: August 5, 2008
Results First Received: September 18, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
overweight
sedentary lifestyle
exercise
primary health care
controlled clinical trials, randomized

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2015