The VA-STRIDE Study

Expert System-Based Feedback in Sedentary Overweight Veterans

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Sedentary Lifestyle
• Intervention / Treatment: Behavioral: Expert system-based physical activity counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 0
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	Month 6
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	Month 12
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	Month 0
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	Month 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	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight in kilograms (kg) measured at Month 0	Month 0
Weight	Weight in kilograms at measured at Month 6	Month 6
Weight	Weight in kilograms measured at Month 12	Month 12
Systolic Blood Pressure (BP)	Systolic BP in millimeters of mercury (mmHg) measured at Month 0	Month 0
Systolic BP	Systolic BP measured at Month 6	Month 6
Systolic BP	Systolic BP measured at Month 12	Month 12
Diastolic BP	Diastolic BP measured at Month 0	Month 0
Diastolic BP	Diastolic BP measured at Month 6	Month 6
Diastolic BP	Diastolic BP measured at Month 12	Month 12
Low-density Lipoprotein (LDL) Cholesterol	LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0	Month 0
LDL Cholesterol	LDL cholesterol measured at Month 6	Month 6
LDL Cholesterol	LDL cholesterol measured at Month 12	Month 12
High-density Lipoprotein (HDL) Cholesterol	HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0	Month 0
HDL Cholesterol	HDL cholesterol measured at Month 6	Month 6
HDL Cholesterol	HDL cholesterol measured at Month 12	Month 12
Triglycerides	Triglycerides measured at Month 0	Month 0
Triglycerides	Triglycerides measured at Month 6	Month 6
Triglycerides	Triglycerides measured at Month 12	Month 12
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.	Month 0
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.	Month 6
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.	Month 12
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.	Month 0
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.	Month 6
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.	Month 12
Physical Function: 6-Minute Walking Distance (6MWD)	Physical Function: 6MWD in meters measured at Month 0	Month 0
Physical Function: 6MWD	Physical Function: 6MWD measured at Month 6	Month 6
Physical Function: 6MWD	Physical Function: 6MWD measured at Month 12	Month 12

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Collaborators: University of Pittsburgh; Brown University
• Investigators: Principal Investigator: Mary Ann Sevick, ScD MS, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Estimate): April 27, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: exercise; overweight; primary health care; sedentary lifestyle; controlled clinical trials, randomized
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: IIR 07-154