Validate STRIDE Exercise Intervention in Sedentary IndividualsCOSTRIDENCT01091857
Mediators and Moderators of Exercise Behavior Change
A study testing STRIDE in people with Validate STRIDE Exercise Intervention in Sedentary Individuals and Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Validate STRIDE Exercise Intervention in Sedentary Individuals, Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions, Increase Self-reported Physical Activity
- What is being tested?
- STRIDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
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.
- Conditions
- Validate STRIDE Exercise Intervention in Sedentary Individuals, Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions, Increase Self-reported Physical Activity
- Being tested
- STRIDE
- Keywords
- Exercise, Transdisciplinary, Physiology, Mood, Motivation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIDEBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention (STRIDE) | Experimental | Not described Receives: Behavioral: STRIDE |
| Health and Wellness Control | Active comparator | Not described Receives: Behavioral: STRIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3,6,9,and 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startSep 2004
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Validate STRIDE Exercise Intervention in Sedentary IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091857
- Sponsor's protocol ID
- 0604.12
- Other IDs
- 1R01CA109858-01
- Acronym
- COSTRIDE
- Status last verified
- Jul 2023
- First submitted
- 22 Mar 2010
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24359456Magnan 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.
PubMed 23088712Magnan 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.
PubMed 22398432
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediators and Moderators of Exercise Behavior Change
- ClinicalTrials.gov ID
- NCT01091857
- Acronym / sponsor ID
- COSTRIDE / 0604.12
- Conditions
- Validate STRIDE Exercise Intervention in Sedentary Individuals, Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions, Increase Self-reported Physical Activity
- Keywords
- Exercise, Transdisciplinary, Physiology, Mood, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention (STRIDE) | Experimental | Behavioral: STRIDE |
| Health and Wellness Control | Active comparator | Behavioral: STRIDE |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIDE | Behavioural | Exercise intervention (STRIDE), Health and Wellness Control |
Primary outcome
Self-reported physical activity
Time frame: 3,6,9,and 12 months post baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 24359456Bryan 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.
- Derived from this study: PubMed 23088712Magnan 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.
- Derived from this study: PubMed 22398432Magnan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRIDE in people with Validate STRIDE Exercise Intervention in Sedentary Individuals and Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical activity (time frame: 3,6,9,and 12 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091857, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.