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OpenTrials
Completed

NCT Number: NCT00367029

Individualized Motivational Print Materials to Encourage More Physical Activity

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In good general health
  • Sedentary
  • Able to speak and read English
  • Planning to live in the area for the duration of the study

Exclusion criteria

  • Currently participates in 91 or more minutes of moderate or vigorous physical activity per week
  • Heart disease
  • Cerebrovascular disease
  • Peripheral vascular disease
  • Chronic obstructive pulmonary disease
  • Diabetes
  • High blood pressure
  • History of gastric bypass surgery
  • Psychoses
  • Any serious medical problem that would make exercise unsafe or unwise
  • Prior participation in a hospital-based or medically supervised weight loss program
  • Excessive alcohol consumption
  • Pregnant or plans to become pregnant

Treatment and study plan

Individualized Print-Based Motivational Program

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Moderators and mediators of the intervention (e.g., motivation and enjoyment)

    Time frame: Measured at Months 6 and 12

  2. Cost-effectiveness

    Time frame: Measured at Months 6 and 12

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Achieving Physical Activity Guidelines Through an Enhanced Print Intervention

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Aug 22, 2006
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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