The VA-STRIDE Study

Obesity Clinical Trial

Official title:

Expert System-Based Feedback in Sedentary Overweight Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731094
• Other study ID #: IIR 07-154
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: April 6, 2015
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Sedentary Lifestyle

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Brown University, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Weight	Weight in kilograms (kg) measured at Month 0	Month 0	No
Secondary	Weight	Weight in kilograms at measured at Month 6	Month 6	No
Secondary	Weight	Weight in kilograms measured at Month 12	Month 12	No
Secondary	Systolic Blood Pressure (BP)	Systolic BP in millimeters of mercury (mmHg) measured at Month 0	Month 0	No
Secondary	Systolic BP	Systolic BP measured at Month 6	Month 6	No
Secondary	Systolic BP	Systolic BP measured at Month 12	Month 12	No
Secondary	Diastolic BP	Diastolic BP measured at Month 0	Month 0	No
Secondary	Diastolic BP	Diastolic BP measured at Month 6	Month 6	No
Secondary	Diastolic BP	Diastolic BP measured at Month 12	Month 12	No
Secondary	Low-density Lipoprotein (LDL) Cholesterol	LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0	Month 0	No
Secondary	LDL Cholesterol	LDL cholesterol measured at Month 6	Month 6	No
Secondary	LDL Cholesterol	LDL cholesterol measured at Month 12	Month 12	No
Secondary	High-density Lipoprotein (HDL) Cholesterol	HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0	Month 0	No
Secondary	HDL Cholesterol	HDL cholesterol measured at Month 6	Month 6	No
Secondary	HDL Cholesterol	HDL cholesterol measured at Month 12	Month 12	No
Secondary	Triglycerides	Triglycerides measured at Month 0	Month 0	No
Secondary	Triglycerides	Triglycerides measured at Month 6	Month 6	No
Secondary	Triglycerides	Triglycerides measured at Month 12	Month 12	No
Secondary	Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)	HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.	Month 0	No
Secondary	HRQL: SF-36 PCS	HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.	Month 6	No
Secondary	HRQL: SF-36 PCS	HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.	Month 12	No
Secondary	HRQL: SF-36 Mental Component Summary Measure (MSC)	HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.	Month 0	No
Secondary	HRQL: SF-36 MCS	HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.	Month 6	No
Secondary	HRQL: SF-36 MCS	HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.	Month 12	No
Secondary	Physical Function: 6-Minute Walking Distance (6MWD)	Physical Function: 6MWD in meters measured at Month 0	Month 0	No
Secondary	Physical Function: 6MWD	Physical Function: 6MWD measured at Month 6	Month 6	No
Secondary	Physical Function: 6MWD	Physical Function: 6MWD measured at Month 12	Month 12	No