The VA-STRIDE Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brown University
University of Pittsburgh
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00731094
First received: August 5, 2008
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

The purpose of the study is to examine the effectiveness and cost-utility of an expert-system, print-based physical activity intervention delivered to Veterans receiving primary care at the VA Pittsburgh Healthcare System.


Condition Intervention
Overweight
Obesity
Sedentary Lifestyle
Behavioral: Expert system-based physical activity counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Expert System-Based Feedback in Sedentary Overweight Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    The primary outcome of the study is a comparison of participant-specific responses to the Community Healthy Activity Model Program for Seniors (CHAMPS) Questionnaire at Baseline, 6-Months, and 12-Months.

    Seven-day accelerometer data collected at the same timepoints supplement the CHAMPS measure of physical activity.



Enrollment: 232
Study Start Date: June 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Expert system-based physical activity counseling
Behavioral: Expert system-based physical activity counseling
The intervention will include 14 mailings to participants that involve completion of physical activity questionnaires printed on forms that will be 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 also will be part of the mailing program.
No Intervention: Arm 2
Baseline physical activity advice followed by standard primary care

Detailed Description:

A.1 The primary aim of the study is to determine the effect of a physical activity intervention designed to increase physical activity for sedentary Veterans at the VA Pittsburgh Healthcare System.

A.2. Secondary aims are to assess key health-related outcomes related to the intervention including health and quality of life. The specific outcomes are to (a) estimate the impact of the intervention on physical function, health-related quality of life (HRQL), weight, blood pressure and serum lipids; (b) characterize variation in intervention effectiveness by participant sociodemographic and health characteristics, such as age, race, and baseline health status; and (c) estimate cost-per-Quality Adjusted Life Year (QALY) at 12 months.

232 Veterans were randomized to intervention or control groups. Participants had a self-reported sedentary lifestyle and a body mass index (BMI) >= 25.0 kg/m2. Those randomized to the intervention received a 12-month intervention 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. Those randomized to the control received limited advice at baseline from a health educator to become more physically active, followed by routine primary care for 12 months with an attention control focused on healthy lifestyle issues other than physical activity. Assessment of effectiveness occurred at baseline, 6, and 12 months. Cost analyses were performed from a payer perspective.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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/m2 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 pulmonary hypertension, 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 in the next 12 months
  • VAPHS employee
  • current participant in another interventional research study that may confound outcomes
  • unable or unwilling to provide signed, informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731094

Locations
United States, Pennsylvania
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Brown University
University of Pittsburgh
Investigators
Principal Investigator: Mary Ann Sevick, ScD MS Center for Health Equity Research and Promotion
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00731094     History of Changes
Other Study ID Numbers: IIR 07-154
Study First Received: August 5, 2008
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
overweight
sedentary lifestyle
exercise
primary health care
controlled clinical trials, randomized

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014