Mediators and Moderators of Exercise Behavior Change

NCT ID: NCT01091857

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-08-31

Brief Summary

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Rates of cancer and cardiovascular disease have shown very little improvement over the past two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming rate. Recent reports estimate that approximately 30% of total cancer deaths are related to poor exercise and nutrition, and other reports have suggested that, when taking into consideration both cardiovascular disease and cancer, inactivity contributes to as many as 250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular physical activity in the prevention of cancer and other debilitating illnesses, 75% of the U.S. population do not get the recommended amount of physical activity as defined by 30 minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40% of the population is completely sedentary (USDHHS, 19960. The objective of the proposed research is to understand the mediators and moderators of a well-tested individually tailored, print-based intervention to increase exercise behavior among sedentary adults. Using a randomized, controlled intervention ton trial, the proposed study will address three primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals initiate and maintain a moderate intensity physical activity regimen, as compared to a health and wellness control intervention, 2) Increases in positive attitudes, perceived normative support, self-efficacy, and intentions to exercise will mediate the effectiveness of the intervention, 3) That increased positive mood, and better temperature, stress, and lactate regulation immediately after exercise challenge (assessed in the laboratory) will moderate the effectiveness of the intervention, and 4) Secondarily, we will test whether gender, race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the effectiveness of the intervention. The rigorous assessment of how and for whom an exercise promotion intervention is effective will provide information for future development of intervention strategies and content, as well as allow the targeting of exercise content to individuals for whom it is most likely to be effective.

Detailed Description

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Conditions

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Validate STRIDE Exercise Intervention in Sedentary Individuals Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions Increase Self-reported Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Exercise intervention (STRIDE)

Group Type EXPERIMENTAL

STRIDE

Intervention Type BEHAVIORAL

Health and Wellness Control

Group Type ACTIVE_COMPARATOR

STRIDE

Intervention Type BEHAVIORAL

Interventions

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STRIDE

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All participants were required to exercise less than 90 minutes per week on average, have a body mass index (BMI) between 18 and 37.5, be physically capable of engaging in moderate-intensity physical activity, have a regular menstrual cycle (if female), be willing to be randomly chosen for one of the two interventions, and give informed consent.

Exclusion Criteria

* Individuals were excluded if they smoked cigarettes, were on a restricted diet, taking psychotropic medications, receiving treatment for any psychiatric disorder, diabetic, had a history of cardiovascular or respiratory disease, had the flu or illness in the previous month, or were pregnant (if female).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

References

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Bryan AD, Magnan RE, Hooper AE, Ciccolo JT, Marcus B, Hutchison KE. Colorado stride (COSTRIDE): testing genetic and physiological moderators of response to an intervention to increase physical activity. Int J Behav Nutr Phys Act. 2013 Dec 21;10:139. doi: 10.1186/1479-5868-10-139.

Reference Type DERIVED
PMID: 24359456 (View on PubMed)

Magnan RE, Kwan BM, Bryan AD. Effects of current physical activity on affective response to exercise: physical and social-cognitive mechanisms. Psychol Health. 2013;28(4):418-33. doi: 10.1080/08870446.2012.733704. Epub 2012 Oct 23.

Reference Type DERIVED
PMID: 23088712 (View on PubMed)

Magnan RE, Kwan BM, Ciccolo JT, Gurney B, Mermier CM, Bryan AD. Aerobic capacity testing with inactive individuals: the role of subjective experience. J Phys Act Health. 2013 Feb;10(2):271-9. doi: 10.1123/jpah.10.2.271. Epub 2012 Feb 29.

Reference Type DERIVED
PMID: 22398432 (View on PubMed)

Other Identifiers

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1R01CA109858-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0604.12

Identifier Type: -

Identifier Source: org_study_id

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