Clinical trial NCT02036593: Community Approaches to Cardiovascular Health: Pathways to Heart Health
Official title: Community Approaches to Cardiovascular Health: Pathways to Heart Health (CATCH-PATH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Keywords: Cardiovascular Risk Factors
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-01-15
Enrollment: 695
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years old and over
* Residents of Detroit, MI

Exclusion Criteria:

* 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:

  1. Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?
  2. Do you feel pain in your chest when you do physical activity?
  3. In the past month, have you had chest pain when you were not doing physical activity?
  4. Do you lose your balance because of dizziness or do you ever lose consciousness?
  5. Do you have a bone or joint problem that could be made worse by a change in physical activity?
  6. Do you have type I diabetes, sometimes called juvenile onset diabetes?
  7. Has your doctor advised you NOT to participate in exercise because of any of the above reasons?
  8. 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?

Primary outcomes:
measure: Pedometer steps
timeFrame: Pedometer data will be uploaded for each participant at each session, at least weekly, throughout the 32 week program
Secondary outcomes:
measure: Health risk assessment
timeFrame: Health risk assessments conducted at baseline, 8 weeks, 32 weeks
measure: Walking group session attendance
timeFrame: Attendance taken at each session (3 times per week) to determine average weekly attendance; over the 32 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy J Schulz, PhD
role: PRINCIPAL_INVESTIGATOR
References: