BACKGROUND: Project Active is a randomized clinical trial that compares a lifestyle physical activity intervention with a traditional structured exercise intervention. The purpose of this paper is to report 6-month results of these interventions on cardiovascular disease (CVD) risk factors among healthy, sedentary, middle-aged men and women, and to examine the psychological strategies used in each group (Lifestyle and Structured) to reach the level of physical activity recommended by the Centers for Disease Control and Prevention (CDC) and American College of Sports Medicine (ACSM) and to achieve changes in these CVD risk factors. METHODS: A total of 116 initially sedentary men (mean +/- SD self-reported physical activity, 33.2 +/- 1.4 kcal.kg-1.day-1) and 119 women (32.9 +/- 1.0 kcal.kg-1.day-1), ages 35-60 years (46.0 +/- 6.7 years) were randomly assigned to a 6-month lifestyle physical activity counseling intervention or a 6-month gymnasium-based structured program. At baseline and 6 months, changes in lipid and lipoprotein-cholesterol concentrations, blood pressure, and body composition and cognitive and behavioral measures of change were assessed. One-way analyses of variance with covariate adjustment were used to test for between-group differences in CVD risk factors. Associations between achieving the CDC/ACSM criterion and changes in cognitive and behavioral measures were assessed with multiple logistic regression models. RESULTS: After 6 months of intervention, 78% of Lifestyle participants and 85% of Structured participants were meeting or exceeding the CDC/ACSM recommendation of accumulating 30 min or more of moderate-intensity physical activity on most, preferably all, days of the week. This was verified by a significant increase in cardiorespiratory fitness in both groups. The adjusted mean increase in maximal METs (VO2peak divided by 3.5 ml.kg-1.min-1) between treadmill tests was 0.4 kcal.kg-1.hr-1 (P < 0.001) for Lifestyle and 1.1 kcal.kg-1.hr-1 (P < 0.001) for Structured. There was a significant difference between intervention groups for this outcome. Both groups had significant reductions in total cholesterol, total cholesterol/HDL-C ratio, diastolic blood pressure, and percentage of body fat. There were no significant between-group differences in changes in these outcomes. Adjusted mean changes in total cholesterol, systolic blood pressure, and percentage of body fat in Lifestyle [in Structured] participants were -0.2 [-0.3] mmol.L-1, -3.2[-1.8] mm Hg, and -1.4 [-1.7] %, respectively. There were significant associations between achieving the CDC/ACSM physical activity criterion and greater use of the cognitive and behavioral strategies of change. Both groups changed self-efficacy and many of the behavioral measures, but there were no significant differences between intervention groups. CONCLUSIONS: These results demonstrate that lifestyle physical activity counseling is as effective as structured exercise programs in increasing physical activity and improving CVD risk factors after 6 months among initially sedentary men and women. Furthermore, specific cognitive and behavioral counseling strategies were increased significantly as a result of the intervention. These strategies are effective and could be used in a wide variety of settings.
RCT Entities:
BACKGROUND: Project Active is a randomized clinical trial that compares a lifestyle physical activity intervention with a traditional structured exercise intervention. The purpose of this paper is to report 6-month results of these interventions on cardiovascular disease (CVD) risk factors among healthy, sedentary, middle-aged men and women, and to examine the psychological strategies used in each group (Lifestyle and Structured) to reach the level of physical activity recommended by the Centers for Disease Control and Prevention (CDC) and American College of Sports Medicine (ACSM) and to achieve changes in these CVD risk factors. METHODS: A total of 116 initially sedentary men (mean +/- SD self-reported physical activity, 33.2 +/- 1.4 kcal.kg-1.day-1) and 119 women (32.9 +/- 1.0 kcal.kg-1.day-1), ages 35-60 years (46.0 +/- 6.7 years) were randomly assigned to a 6-month lifestyle physical activity counseling intervention or a 6-month gymnasium-based structured program. At baseline and 6 months, changes in lipid and lipoprotein-cholesterol concentrations, blood pressure, and body composition and cognitive and behavioral measures of change were assessed. One-way analyses of variance with covariate adjustment were used to test for between-group differences in CVD risk factors. Associations between achieving the CDC/ACSM criterion and changes in cognitive and behavioral measures were assessed with multiple logistic regression models. RESULTS: After 6 months of intervention, 78% of Lifestyle participants and 85% of Structured participants were meeting or exceeding the CDC/ACSM recommendation of accumulating 30 min or more of moderate-intensity physical activity on most, preferably all, days of the week. This was verified by a significant increase in cardiorespiratory fitness in both groups. The adjusted mean increase in maximal METs (VO2peak divided by 3.5 ml.kg-1.min-1) between treadmill tests was 0.4 kcal.kg-1.hr-1 (P < 0.001) for Lifestyle and 1.1 kcal.kg-1.hr-1 (P < 0.001) for Structured. There was a significant difference between intervention groups for this outcome. Both groups had significant reductions in total cholesterol, total cholesterol/HDL-C ratio, diastolic blood pressure, and percentage of body fat. There were no significant between-group differences in changes in these outcomes. Adjusted mean changes in total cholesterol, systolic blood pressure, and percentage of body fat in Lifestyle [in Structured] participants were -0.2 [-0.3] mmol.L-1, -3.2[-1.8] mm Hg, and -1.4 [-1.7] %, respectively. There were significant associations between achieving the CDC/ACSM physical activity criterion and greater use of the cognitive and behavioral strategies of change. Both groups changed self-efficacy and many of the behavioral measures, but there were no significant differences between intervention groups. CONCLUSIONS: These results demonstrate that lifestyle physical activity counseling is as effective as structured exercise programs in increasing physical activity and improving CVD risk factors after 6 months among initially sedentary men and women. Furthermore, specific cognitive and behavioral counseling strategies were increased significantly as a result of the intervention. These strategies are effective and could be used in a wide variety of settings.
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