Clinical trial NCT00731094: The VA-STRIDE Study
Official title: Expert System-Based Feedback in Sedentary Overweight Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Sedentary Lifestyle
Keywords: overweight
sedentary lifestyle
exercise
primary health care
controlled clinical trials, randomized
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Brown University
name: University of Pittsburgh
First posted: 2008-08-08
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
timeFrame: Month 0
measure: Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire
timeFrame: Month 6
measure: Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire
timeFrame: Month 12
measure: Moderate Intensity Physical Activity: Accelerometer
timeFrame: Month 0
measure: Moderate Intensity Physical Activity: Accelerometer
timeFrame: Month 6
measure: Moderate Intensity Physical Activity: Accelerometer
timeFrame: Month 12
Secondary outcomes:
measure: Weight
timeFrame: Month 0
measure: Weight
timeFrame: Month 6
measure: Weight
timeFrame: Month 12
measure: Systolic Blood Pressure (BP)
timeFrame: Month 0
measure: Systolic BP
timeFrame: Month 6
measure: Systolic BP
timeFrame: Month 12
measure: Diastolic BP
timeFrame: Month 0
measure: Diastolic BP
timeFrame: Month 6
measure: Diastolic BP
timeFrame: Month 12
measure: Low-density Lipoprotein (LDL) Cholesterol
timeFrame: Month 0
measure: LDL Cholesterol
timeFrame: Month 6
measure: LDL Cholesterol
timeFrame: Month 12
measure: High-density Lipoprotein (HDL) Cholesterol
timeFrame: Month 0
measure: HDL Cholesterol
timeFrame: Month 6
measure: HDL Cholesterol
timeFrame: Month 12
measure: Triglycerides
timeFrame: Month 0
measure: Triglycerides
timeFrame: Month 6
measure: Triglycerides
timeFrame: Month 12
measure: Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)
timeFrame: Month 0
measure: HRQL: SF-36 PCS
timeFrame: Month 6
measure: HRQL: SF-36 PCS
timeFrame: Month 12
measure: HRQL: SF-36 Mental Component Summary Measure (MSC)
timeFrame: Month 0
measure: HRQL: SF-36 MCS
timeFrame: Month 6
measure: HRQL: SF-36 MCS
timeFrame: Month 12
measure: Physical Function: 6-Minute Walking Distance (6MWD)
timeFrame: Month 0
measure: Physical Function: 6MWD
timeFrame: Month 6
measure: Physical Function: 6MWD
timeFrame: Month 12
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Mary Ann Sevick, ScD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.