Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT00731094
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The VA-STRIDE Study
Sponsor:
US Department of Veterans Affairs
Organization:
Study Overview
Official Title:
Expert System-Based Feedback in Sedentary Overweight Veterans
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: