The VA-STRIDE Study

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Overweight; Obesity; Sedentary Lifestyle

Treatments: Behavioral: Expert system-based physical activity counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00731094

IIR 07-154

Details and patient eligibility

About

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).

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 2 patient groups

Physical Activity Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Expert system-based physical activity counseling

Attention Control

No Intervention group

Description:

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