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CompletedNCT00367029Updated May 7, 2014

Individualized Motivational Print Materials to Encourage More Physical Activity

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

Phase
Phase 3
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Physical Activity
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
256 participants (actual)

Study arms

  • Active comparator
    1

    Print-based, individually tailored motivational program

    Behavioral: Individualized Print-Based Motivational Program

  • Experimental
    2

    Enhanced version of the print-based, individually tailored motivational program

    Behavioral: Individualized Print-Based Motivational Program

Interventions

  • BehavioralIndividualized 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.

06

What researchers measure

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

07

Study locations

1 site
  • Centers for Behavioral and Preventive Medicine, The Miriam Hospital
    Providence, Rhode Island 02903, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00367029
Lead sponsor
The Miriam Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
First posted
Aug 22, 2006
Start date
Aug 2006
Primary completion
Apr 2011
Completion
Apr 2011
Last update
May 7, 2014

Study contacts

Bess H. Marcus, PhD
principal investigator · The Miriam Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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