Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Pittsburgh, Pennsylvania 15206


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.


Study summary:

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.


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


NCT ID:

NCT00731094


Primary Contact:

Principal Investigator
Mary Ann Sevick, ScD MS
Center for Health Equity Research and Promotion


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15206
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.