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Individualized Motivational Print Materials to Encourage More Physical Activity

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00367029
First received: August 18, 2006
Last updated: May 6, 2014
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Behavioral: Individualized Print-Based Motivational Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Achieving Physical Activity Guidelines Through an Enhanced Print Intervention

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Moderators and mediators of the intervention (e.g., motivation and enjoyment) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 256
Study Start Date: August 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.

Experimental: 2
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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367029

Locations
United States, Rhode Island
Centers for Behavioral and Preventive Medicine, The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Bess H. Marcus, PhD The Miriam Hospital
  More Information

No publications provided

Responsible Party: The Miriam Hospital, Centers for Behavioral and Preventive Medicine
ClinicalTrials.gov Identifier: NCT00367029     History of Changes
Other Study ID Numbers: 408, R01HL064342-05, R01 HL064342-05
Study First Received: August 18, 2006
Last Updated: May 6, 2014
Health Authority: United States: Federal Government

Keywords provided by The Miriam Hospital:
Physical Activity

ClinicalTrials.gov processed this record on November 20, 2014