Examining Psychosocial Mediators of Exercise Behavior

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT00142688
First received: September 1, 2005
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to examine psychosocial mediators of exercise behavior.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Behavioral: Physical activity
Behavioral: Wellness
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Examining Psychosocial Mediators of Exercise Behavior

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • Physical activity [ Time Frame: Measured at baseline, 6, and 12 months ] [ Designated as safety issue: No ]

Enrollment: 448
Study Start Date: August 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tailored print-based intervention in which participants complete questionnaires and receive tailored feedback based on responses to the questionnaires. The intervention is delivered monthly during the first month, bi-monthly during months 2 and 3, and monthly during months 4-6. The intervention is completed through the mail.
Behavioral: Physical activity
Tailored print-based intervention in which participants complete questionnaires and receive tailored feedback based on responses to the questionnaires. The intervention is delivered monthly during the first month, bi-monthly during months 2 and 3, and monthly during months 4-6. The intervention is completed through the mail.
Active Comparator: 2
Participants receive wellness materials delivered through the mail on the same schedule as the experimental condition. Physical activity materials are given to this group upon completion of the study.
Behavioral: Wellness
Participants receive wellness materials delivered through the mail on the same schedule as the experimental condition. Physical activity materials are given to this group upon completion of the study.

Detailed Description:

BACKGROUND:

Physical inactivity is related to many health problems, including increased risk of cardiovascular disease, hypertension, and cancer. Despite the health consequences of a sedentary lifestyle, only 25 percent of Americans meet the recommended levels of physical activity. Researchers postulate that theory-based interventions effectively influence physical activity behavior by changing theoretical constructs believed to be important for behavior change (i.e., potential mediators), such as self-efficacy (i.e., confidence in one's ability to be physically active). Unfortunately, previous studies have generally failed to adequately test the mediating effect of theoretical constructs using appropriate statistical mediator analyses as recommended by leading behavioral scientists and statisticians.

DESIGN NARRATIVE:

The study will examine the mediating effect of theoretical constructs based on the Transtheoretical Model (TTM) and Social Cognitive Theory (SCT). The study will address the methodological, measurement, and statistical limitations of previous studies. The investigators will randomly assign 420 healthy sedentary individuals to either a theory-based physical activity intervention or a contact control group. Physical activity behavior and the potential mediators will be assessed monthly over 12 months. They hypothesize that constructs based on the TTM and SCT (i.e., behavioral processes, cognitive processes, self-efficacy, and decisional balance) will mediate the relationship between group assignment (intervention vs. contact control) and physical activity behavior, such that the effect of the intervention on physical activity behavior relative to the contact control group will be attenuated when controlling for the mediators. They will also examine the importance of particular mediators for different population groups (e.g., age, gender), which will help to create more effective interventions for these groups. Finally, they will conduct a cost analysis to not only inform policy makers of the cost of delivering the intervention within our study but also to estimate the cost of delivering each component of the intervention (i.e., mediator). The analysis will estimate the cost of future refined interventions that incorporate those active components that affect the mediators and physical activity in this study. In summary, the study will identify which mediators (i.e., theoretical constructs) are most effective for increasing physical activity, which will have an important public health impact given that this will likely lead to more efficacious and less costly interventions.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health
  • Living a sedentary lifestyle
  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: NCT00142688

Locations
United States, Minnesota
Health Partners Research Foundation
Minneapolis, Minnesota, United States, 55440
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Beth A. Lewis, PhD Health Partners Research Foundation
  More Information

Publications:
Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT00142688     History of Changes
Other Study ID Numbers: 253, R01HL072947, R01 HL72947
Study First Received: September 1, 2005
Last Updated: August 21, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 16, 2014