The VA-STRIDE Study

Not Applicable

Completed

Conditions: Obesity
Sedentary Lifestyle
Overweight

Interventions: Behavioral: Expert system-based physical activity counseling

Registration Number: NCT00731094

Lead Sponsor: US Department of Veterans Affairs

Brief 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 232

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Intervention	Expert system-based physical activity counseling	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

Primary Outcome Measures

Name	Time	Method
Moderate Intensity Physical Activity: Accelerometer	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
Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire	Month 0	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	Month 12	Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire

Secondary Outcome Measures

Name	Time	Method
Low-density Lipoprotein (LDL) Cholesterol	Month 0	LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0
Triglycerides	Month 12	Triglycerides measured at Month 12
Weight	Month 12	Weight in kilograms measured at Month 12
Systolic Blood Pressure (BP)	Month 0	Systolic BP in millimeters of mercury (mmHg) measured at Month 0
Diastolic BP	Month 12	Diastolic BP measured at Month 12
High-density Lipoprotein (HDL) Cholesterol	Month 0	HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0
HRQL: SF-36 PCS	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.
Systolic BP	Month 12	Systolic BP measured at Month 12
LDL Cholesterol	Month 12	LDL cholesterol measured at Month 12
Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)	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.
HRQL: SF-36 MCS	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.
Physical Function: 6MWD	Month 12	Physical Function: 6MWD measured at Month 12
HDL Cholesterol	Month 12	HDL cholesterol measured at Month 12
HRQL: SF-36 Mental Component Summary Measure (MSC)	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.
Physical Function: 6-Minute Walking Distance (6MWD)	Month 0	Physical Function: 6MWD in meters measured at Month 0