Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
232 participants
INTERVENTIONAL
2010-06-30
2013-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking
NCT04518943
The Clinical Referral to Activity Study
NCT04743856
Increasing Steps Per Day in Rural Veterans
NCT03930238
Exercise Instruction Via Phone or Print
NCT00200278
Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
NCT02360293
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Physical Activity Intervention
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
Expert system-based physical activity counseling
The intervention included 14 mailings to participants 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 and related manuals based on the Stages of Motivational Readiness for Change Model. Newsletters providing additional support and suggestions for increasing physical activity were also part of the mailing program.
Attention Control
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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Expert system-based physical activity counseling
The intervention included 14 mailings to participants 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 and related manuals based on the Stages of Motivational Readiness for Change Model. Newsletters providing additional support and suggestions for increasing physical activity were also part of the mailing program.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brown University
OTHER
University of Pittsburgh
OTHER
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mary Ann Sevick, ScD MS
Role: PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIR 07-154
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.