The VA-STRIDE Study

NCT00731094 | Completed Results DMC

• 1 other identifier: IIR 07-154
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight; Obesity; Sedentary Lifestyle

Keywords

overweight; sedentary lifestyle; exercise; primary health care; controlled clinical trials, randomized

Outcome Measures

Primary Outcomes (6)

• Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire

  Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire

  Month 0

• Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire

  Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire

  Month 6

• Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire

  Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire

  Month 12

• Moderate Intensity Physical Activity: Accelerometer

  Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0

  Month 0

• Moderate Intensity Physical Activity: Accelerometer

  Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6

  Month 6

• Moderate Intensity Physical Activity: Accelerometer

  Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12

  Month 12

Secondary Outcomes (27)

• Weight

  Month 0

• Weight

  Month 6

• Weight

  Month 12

• Systolic Blood Pressure (BP)

  Month 0

• Systolic BP

  Month 6

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

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

Behavioral: Expert system-based physical activity counseling

Attention Control

NO INTERVENTION

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

Interventions

Expert system-based physical activity counseling BEHAVIORAL

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.

Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Brown University: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (2)

• 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.

  PMID: 24398076 RESULT

• 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.

  PMID: 26844197 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Kelly Hyman Burkitt, PhD
• Organization: VA Pittsburgh Healthcare System

Kelly.Burkitt@va.gov

412-360-2202

Study Officials

• Mary Ann Sevick, ScD MS

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 27, 2015
• Results First Posted: October 30, 2014

Record last verified: 2014-03

Locations

US (1)