Cardiovascular Risk FactorsCATCH-PATHNCT02036593
Community Approaches to Cardiovascular Health: Pathways to Heart Health
A study testing Walk Your Heart to Health in people with Cardiovascular Risk Factors, run by University of Michigan at 1 site in United States.
Trial summary
The Specific Aims for CATCH: PATH are: Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase opportunities for active living, specifically walking groups, in three communities in Detroit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Walk Your Heart to Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 695 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Feb 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years old and over
- Residents of Detroit, MI
Who cannot join
- Individual has a legal guardian
- Individual is pregnant and delivery is expected within the next 5 months
- Individual answers yes to any of the following questions on a screening questionnaire and DOES NOT provide a medical clearance from his/her physician:
- Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?
- Do you feel pain in your chest when you do physical activity?
- In the past month, have you had chest pain when you were not doing physical activity?
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- Do you lose your balance because of dizziness or do you ever lose consciousness?
- Do you have a bone or joint problem that could be made worse by a change in physical activity?
- Do you have type I diabetes, sometimes called juvenile onset diabetes?
- Has your doctor advised you NOT to participate in exercise because of any of the above reasons?
- Are you aware, through your own experience or doctors advice, of any other physical reason which would prevent you from exercising without medical supervision or specific instructions from a doctor?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Approaches to Cardiovascular Health: Pathways to Heart Health (CATCH-PATH)
The Specific Aims for CATCH: PATH are:
Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase opportunities for active living, specifically walking groups, in three communities in Detroit.
Read more
Specific Aim 2: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., organization, community, policy levels) to promote leadership development, community action, and policy level change to enhance neighborhood environments that support and sustain active living.
Specific Aim 3: To maintain and evaluate the HEP CBPR partnership engaging members of the partnership in providing scientific and community oversight for all aspects of the CATCH: PATH project.
Specific Aim 4: To disseminate preliminary results and develop a comprehensive Dissemination Plan to share research findings through community and peer reviewed outlets to assure translation of results from this multilevel CBPR intervention into programmatic and policy efforts to improve heart health in eastside, northwest and southwest Detroit.
Read the detailed description
The Specific Aims for CATCH: PATH are:
Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase opportunities for active living, specifically walking groups, in three communities in Detroit.
Specific Aim 2: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., organization, community, policy levels) to promote leadership development, community action, and policy level change to enhance neighborhood environments that support and sustain active living.
Specific Aim 3: To maintain and evaluate the HEP CBPR partnership engaging members of the partnership in providing scientific and community oversight for all aspects of the CATCH: PATH project.
Specific Aim 4: To disseminate preliminary results and develop a comprehensive Dissemination Plan to share research findings through community and peer reviewed outlets to assure translation of results from this multilevel CBPR intervention into programmatic and policy efforts to improve heart health in eastside, northwest and southwest Detroit.
Research Questions and Hypotheses
In Aim 1, we intend to assess the short term (8 week) and longer term (10 month) effectiveness of a multilevel CBPR intervention (i.e., individual, family, organizational levels) designed to improve heart health through enhanced opportunities for active living, specifically walking groups, in three communities in Detroit. Hypotheses to be tested are:
Participation in an 8-week intensive walking group intervention will reduce risk factors and increase protective factors associated with CVD among African American, Latino and white residents of low to moderate income neighborhoods in Detroit.
H1.1: Physical activity will increase (physical inactivity will be reduced). H1.2: Psychosocial factors positively associated with physical activity (e.g., confidence in ability to be physically active most days of the week) will increase.
H1.3: Anthropometric indicators of CVD risk (e.g., BMI, waist circumference) will not change significantly.
H1.4: Biological indicators of CVD risk (e.g., lipid levels) will not change significantly.
Participation in a less intensive, maintenance walking group intervention over a 10 month period following the initial intensive walking groups will sustain changes in physical activity, further improvements in psychosocial factors associated with reduced risk, and reductions in biological and anthropomorphic risk factors and improvements in protective factors among participants.
H2.1: Increases in physical activity from baseline will be sustained during the maintenance period (physical inactivity will be reduced from baseline).
H2.2: Increases in psychosocial factors positively associated with physical activity (e.g., confidence in ability to be physically active most days of the week) will be enhanced (improved at 12 months over baseline and over the immediate post-intervention follow up).
H2.3: Anthropometric indicators of CVD risk (e.g., BMI, waist circumference) will be reduced at 12 months compared to baseline.
H2.4: Biological indicators of CVD risk (e.g., LDL levels) will be reduced and protective indicators (e.g., HDL) increased at 12 months compared to baseline.
In Aim 2, we will assess the feasibility of promoting heart health by providing support for leadership development, organizational change, community action and policy change to enhance neighborhood environments that support and sustain active living. Research questions will examine: the extent to which provision of technical assistance and facilitator training to community organizations can support the development and maintenance of walking groups and the extent to which a mini-grant program contributes to modifications of the built and social environment to support active living. These exploratory research questions, essential to the dissemination and sustainability of community-based interventions addressing disparities in CVD, will not be tested as formal hypotheses. Rather, we will focus on documenting change, and identifying challenges, facilitating factors, and lessons learned to inform subsequent more formal hypotheses-testing.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Walk Your Heart to Health
- Keywords
- Cardiovascular Risk Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk Your Heart to HealthBehavioural
Walking group sessions conducted 3 times per week for 32 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Walk Your Heart to Health intervention | Experimental | Participants were randomized into one of two groups: intervention and lagged intervention. The intervention group completed the 8 week Walk Your Heart to Health intervention, followed by a second wave of data collection for both initial and lagged intevention groups. The lagged intervention group then completed the 8 week Walk Your Heart to Health intervention. Both groups continued walking for another 24 weeks.
Walking group sessions conducted 3 times per week for 32 weeks. Receives: Behavioral: Walk Your Heart to Health |
| Walk Your Heart to Health lagged | Other | Participants were randomized into one of two groups: intervention and lagged intervention. The intervention group completed the 8 week Walk Your Heart to Health intervention, followed by a second wave of data collection for both initial and lagged intevention groups. The lagged intervention group then completed the 8 week Walk Your Heart to Health intervention. Both groups continued walking for another 24 weeks.
Walking group sessions conducted 3 times per week for 32 weeks. Receives: Behavioral: Walk Your Heart to Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedometer steps
Measured: Pedometer data will be uploaded for each participant at each session, at least weekly, throughout the 32 week program
Secondary outcomes (2)
Health risk assessment
The Health risk assessment includes psychosocial, behavioral (self report), and measured anthropometric and clinical indicators of heart health.
Measured: Health risk assessments conducted at baseline, 8 weeks, 32 weeks
Walking group session attendance
Attendance at walking group sessions (3times per week) over the 32 week intervention period.
Measured: Attendance taken at each session (3 times per week) to determine average weekly attendance; over the 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJul 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Amy J. Schulz, University of Michigan
- Investigators
- Amy J Schulz, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036593
- Sponsor's protocol ID
- CATCH-PATH
- Other IDs
- 2R24MD001619-04
- Acronym
- CATCH-PATH
- Status last verified
- Jan 2014
- First submitted
- 17 Dec 2013
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Approaches to Cardiovascular Health: Pathways to Heart Health (CATCH-PATH)
- ClinicalTrials.gov ID
- NCT02036593
- Acronym / sponsor ID
- CATCH-PATH / CATCH-PATH
- Conditions
- Cardiovascular Risk Factors
- Keywords
- Cardiovascular Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jul 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Jan 2014 (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 Specific Aims for CATCH: PATH are:
Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase opportunities for active living, specifically walking groups, in three communities in Detroit.
Specific Aim 2: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., organization, community, policy levels) to promote leadership development, community action, and policy level change to enhance neighborhood environments that support and sustain active living.
Specific Aim 3: To maintain and evaluate the HEP CBPR partnership engaging members of the partnership in providing scientific and community oversight for all aspects of the CATCH: PATH project.
Specific Aim 4: To disseminate preliminary results and develop a comprehensive Dissemination Plan to share research findings through community and peer reviewed outlets to assure translation of results from this multilevel CBPR intervention into programmatic and policy efforts to improve heart health in eastside, northwest and southwest Detroit.
Detailed description
The Specific Aims for CATCH: PATH are:
Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase opportunities for active living, specifically walking groups, in three communities in Detroit.
Specific Aim 2: To promote cardiovascular health through implementation and evaluation of a multilevel CBPR intervention (i.e., organization, community, policy levels) to promote leadership development, community action, and policy level change to enhance neighborhood environments that support and sustain active living.
Specific Aim 3: To maintain and evaluate the HEP CBPR partnership engaging members of the partnership in providing scientific and community oversight for all aspects of the CATCH: PATH project.
Specific Aim 4: To disseminate preliminary results and develop a comprehensive Dissemination Plan to share research findings through community and peer reviewed outlets to assure translation of results from this multilevel CBPR intervention into programmatic and policy efforts to improve heart health in eastside, northwest and southwest Detroit.
Research Questions and Hypotheses
In Aim 1, we intend to assess the short term (8 week) and longer term (10 month) effectiveness of a multilevel CBPR intervention (i.e., individual, family, organizational levels) designed to improve heart health through enhanced opportunities for active living, specifically walking groups, in three communities in Detroit. Hypotheses to be tested are:
Participation in an 8-week intensive walking group intervention will reduce risk factors and increase protective factors associated with CVD among African American, Latino and white residents of low to moderate income neighborhoods in Detroit.
H1.1: Physical activity will increase (physical inactivity will be reduced). H1.2: Psychosocial factors positively associated with physical activity (e.g., confidence in ability to be physically active most days of the week) will increase.
H1.3: Anthropometric indicators of CVD risk (e.g., BMI, waist circumference) will not change significantly.
H1.4: Biological indicators of CVD risk (e.g., lipid levels) will not change significantly.
Participation in a less intensive, maintenance walking group intervention over a 10 month period following the initial intensive walking groups will sustain changes in physical activity, further improvements in psychosocial factors associated with reduced risk, and reductions in biological and anthropomorphic risk factors and improvements in protective factors among participants.
H2.1: Increases in physical activity from baseline will be sustained during the maintenance period (physical inactivity will be reduced from baseline).
H2.2: Increases in psychosocial factors positively associated with physical activity (e.g., confidence in ability to be physically active most days of the week) will be enhanced (improved at 12 months over baseline and over the immediate post-intervention follow up).
H2.3: Anthropometric indicators of CVD risk (e.g., BMI, waist circumference) will be reduced at 12 months compared to baseline.
H2.4: Biological indicators of CVD risk (e.g., LDL levels) will be reduced and protective indicators (e.g., HDL) increased at 12 months compared to baseline.
In Aim 2, we will assess the feasibility of promoting heart health by providing support for leadership development, organizational change, community action and policy change to enhance neighborhood environments that support and sustain active living. Research questions will examine: the extent to which provision of technical assistance and facilitator training to community organizations can support the development and maintenance of walking groups and the extent to which a mini-grant program contributes to modifications of the built and social environment to support active living. These exploratory research questions, essential to the dissemination and sustainability of community-based interventions addressing disparities in CVD, will not be tested as formal hypotheses. Rather, we will focus on documenting change, and identifying challenges, facilitating factors, and lessons learned to inform subsequent more formal hypotheses-testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk Your Heart to Health intervention | Experimental | Behavioral: Walk Your Heart to HealthParticipants were randomized into one of two groups: intervention and lagged intervention. The intervention group completed the 8 week Walk Your Heart to Health intervention, followed by a second wave of data collection for both initial and lagged intevention groups. The lagged intervention group then completed the 8 week Walk Your Heart to Health intervention. Both groups continued walking for another 24 weeks. Walking group sessions conducted 3 times per week for 32 weeks. |
| Walk Your Heart to Health lagged | Other | Behavioral: Walk Your Heart to HealthParticipants were randomized into one of two groups: intervention and lagged intervention. The intervention group completed the 8 week Walk Your Heart to Health intervention, followed by a second wave of data collection for both initial and lagged intevention groups. The lagged intervention group then completed the 8 week Walk Your Heart to Health intervention. Both groups continued walking for another 24 weeks. Walking group sessions conducted 3 times per week for 32 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years old and over
- Residents of Detroit, MI
Key exclusion criteria (11 listed)
- Individual has a legal guardian
- Individual is pregnant and delivery is expected within the next 5 months
- Individual answers yes to any of the following questions on a screening questionnaire and DOES NOT provide a medical clearance from his/her physician:
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 |
|---|---|---|
| Walk Your Heart to HealthWalking group sessions conducted 3 times per week for 32 weeks. | Behavioural | Walk Your Heart to Health intervention, Walk Your Heart to Health lagged |
Primary outcome
Pedometer steps
Time frame: Pedometer data will be uploaded for each participant at each session, at least weekly, throughout the 32 week program
2 secondary outcomes
Health risk assessment
Time frame: Health risk assessments conducted at baseline, 8 weeks, 32 weeks
Walking group session attendance
Time frame: Attendance taken at each session (3 times per week) to determine average weekly attendance; over the 32 weeks
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 15 Jan 2014.
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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.
Amy J Schulz, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk Your Heart to Health in people with Cardiovascular Risk Factors, run by University of Michigan 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 11 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 15 Jan 2014. 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?
Pedometer steps (time frame: Pedometer data will be uploaded for each participant at each session, at least weekly, throughout the 32 week program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2014.