Individualized Motivational Print Materials to Encourage More Physical Activity

NCT00367029 | Completed Phase 3 DMC

• 2 other identifiers: 408R01HL064342-05
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Physical Activity

Outcome Measures

Primary Outcomes (1)

• Achievement of 150 minutes per week of at least moderate intensity physical activity

  Measured by the 7-day Physical Activity Recall test at Months 6 and 12

Secondary Outcomes (2)

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

  Measured at Months 6 and 12

• Cost-effectiveness

  Measured at Months 6 and 12

Study Arms (2)

1

ACTIVE COMPARATOR

Print-based, individually tailored motivational program

Behavioral: Individualized Print-Based Motivational Program

2

EXPERIMENTAL

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

Behavioral: Individualized Print-Based Motivational Program

Interventions

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bess H. Marcus, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 22, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 7, 2014

Record last verified: 2009-03

Locations

US (1)