A Phase 3 interventional study of Individualized Print-Based Motivational Program in Healthy, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-07.
Sponsored by The Miriam Hospital · Phase 3, Interventional, and Treatment
Individuals who are not physically active are at risk for developing heart disease, stroke, and diabetes. Using motivational print materials is one way to encourage individuals to increase their physical activity. This study will evaluate the effect that an enhanced version of an individualized, print-based motivational program has on increasing physical activity among sedentary individuals.
Currently, only 32% of adults in the United States participate in regular physical activity. Several healthcare organizations, including the Centers for Disease Control and Prevention, the National Institutes of Health, and the American Heart Association recommend that adults engage in a minimum of 2 ½ hours of physical activity each week. In a previous study, individuals who received motivational print materials in the mail increased their weekly physical activity more than individuals who received no motivational materials or who received motivational support over the telephone. However, about half of those who were mailed the print materials still did not reach the recommended goal of 2 ½ hours of physical activity per week. The purpose of this study is to compare the effectiveness of an enhanced version of an individualized, print-based motivational program versus a previously tested print-based motivational program at increasing physical activity levels in sedentary individuals.
This study will enroll healthy, sedentary individuals. Participants will be randomly assigned to either a print-based, individually tailored motivational program or an enhanced version of the same program. All participants will attend a baseline study visit, which will include body measurements, physical activity assessments, and health and psychological questionnaires. A select group of participants will also take part in an exercise test. Participants will then document their monthly physical activity. Study researchers will use this information, as well as the completed questionnaires, to develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. At Months 6 and 12, baseline evaluations will be repeated and all participants will be interviewed to assess physical activity levels.
The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Print-based, individually tailored motivational program
Behavioral: Individualized Print-Based Motivational Program
Enhanced version of the print-based, individually tailored motivational program
Behavioral: Individualized Print-Based Motivational Program
Study researchers will develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff.
Achievement of 150 minutes per week of at least moderate intensity physical activity
Time frame: Measured by the 7-day Physical Activity Recall test at Months 6 and 12
Moderators and mediators of the intervention (e.g., motivation and enjoyment)
Time frame: Measured at Months 6 and 12
Cost-effectiveness
Time frame: Measured at Months 6 and 12
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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The Miriam Hospital