NCT01091857

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

4.9 years

First QC Date

March 22, 2010

Last Update Submit

July 7, 2023

Conditions

Keywords

ExerciseTransdisciplinaryPhysiologyMoodMotivation

Outcome Measures

Primary Outcomes (1)

  • Self-reported physical activity

    After being randomly assigned to the exercise or health-and-wellness conditions, participants were followed up every three months for one year at which times they reported their current physical activity.

    3,6,9,and 12 months post baseline

Study Arms (2)

Exercise intervention (STRIDE)

EXPERIMENTAL
Behavioral: STRIDE

Health and Wellness Control

ACTIVE COMPARATOR
Behavioral: STRIDE

Interventions

STRIDEBEHAVIORAL
Exercise intervention (STRIDE)Health and Wellness Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 24, 2010

Study Start

September 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations