Cardiovascular DiseasesPhase 1NCT00142688
Examining Psychosocial Mediators of Exercise Behavior
A Phase 1 study testing Physical activity and Wellness in people with Cardiovascular Diseases and Heart Diseases, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this study is to examine psychosocial mediators of exercise behavior. Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Physical activity and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2008
- Phase
- Phase 1
- 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 Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- In good health
- Living a sedentary lifestyle
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440
About this study
The purpose of this study is to examine psychosocial mediators of exercise behavior.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- Physical activity, Wellness
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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.
WellnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Behavioral: Physical activity |
| 2 | Active comparator | 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. Receives: Behavioral: Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Measured: Measured at baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Beth A. Lewis, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142688
- Sponsor's protocol ID
- 253
- Other IDs
- R01HL072947, A04-102
- Status last verified
- Oct 2015
- First submitted
- 1 Sep 2005
- Last updated
- 29 Oct 2015
- Results posted
- No
Publications
Lewis BA, Williams DM, Martinson BC, Dunsiger S, Marcus BH. Healthy for life: a randomized trial examining physical activity outcomes and psychosocial mediators. Ann Behav Med. 2013 Apr;45(2):203-12. doi: 10.1007/s12160-012-9439-5.
PubMed 23229158Lewis BA, Williams DM, Frayeh A, Marcus BH. Self-efficacy versus perceived enjoyment as predictors of physical activity behaviour. Psychol Health. 2016;31(4):456-69. doi: 10.1080/08870446.2015.1111372. Epub 2015 Nov 18.
PubMed 26541890
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Psychosocial Mediators of Exercise Behavior
- ClinicalTrials.gov ID
- NCT00142688
- Acronym / sponsor ID
- 253
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Sep 2005 (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.
The purpose of this study is to examine psychosocial mediators of exercise behavior.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Physical activityTailored 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. |
| 2 | Active comparator | Behavioral: WellnessParticipants 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. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- In good health
- Living a sedentary lifestyle
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Physical activityTailored 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. | Behavioural | 1 |
| WellnessParticipants 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. | Behavioural | 2 |
Primary outcome
Physical activity
Time frame: Measured at baseline, 6, and 12 months
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 29 Oct 2015.
- Results publication: PubMed 23229158Lewis BA, Williams DM, Martinson BC, Dunsiger S, Marcus BH. Healthy for life: a randomized trial examining physical activity outcomes and psychosocial mediators. Ann Behav Med. 2013 Apr;45(2):203-12. doi: 10.1007/s12160-012-9439-5.
- Derived from this study: PubMed 26541890Lewis BA, Williams DM, Frayeh A, Marcus BH. Self-efficacy versus perceived enjoyment as predictors of physical activity behaviour. Psychol Health. 2016;31(4):456-69. doi: 10.1080/08870446.2015.1111372. Epub 2015 Nov 18.
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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.
Beth A. Lewis, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical activity and Wellness in people with Cardiovascular Diseases and Heart Diseases, run by HealthPartners Institute 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 2 inclusion and 0 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 29 Oct 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical activity (time frame: Measured at baseline, 6, and 12 months). 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 NCT00142688, which also lists 2 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 29 Oct 2015.