Viewing Study NCT02036593


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Study NCT ID: NCT02036593
Status: COMPLETED
Last Update Posted: 2014-01-15
First Post: 2013-12-17
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Community Approaches to Cardiovascular Health: Pathways to Heart Health
Sponsor: University of Michigan
Organization:

Study Overview

Official Title: Community Approaches to Cardiovascular Health: Pathways to Heart Health (CATCH-PATH)
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CATCH-PATH
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
2R24MD001619-04 NIH None https://reporter.nih.gov/quic… View