Expert System-Based Feedback in Sedentary Overweight Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Moderate Intensity Physical Activity: Accelerometer
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Moderate Intensity Physical Activity: Accelerometer
时间窗: Month 12
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
Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
时间窗: Month 0
Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire
Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire
时间窗: Month 12
Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire
次要结局
- Low-density Lipoprotein (LDL) Cholesterol(Month 0)
- Triglycerides(Month 12)
- Weight(Month 12)
- Systolic Blood Pressure (BP)(Month 0)
- Diastolic BP(Month 12)
- High-density Lipoprotein (HDL) Cholesterol(Month 0)
- HRQL: SF-36 PCS(Month 12)
- Systolic BP(Month 12)
- LDL Cholesterol(Month 12)
- Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)(Month 0)
- HRQL: SF-36 MCS(Month 12)
- Physical Function: 6MWD(Month 12)
- HDL Cholesterol(Month 12)
- HRQL: SF-36 Mental Component Summary Measure (MSC)(Month 0)
- Physical Function: 6-Minute Walking Distance (6MWD)(Month 0)