Diet & Activity Community Trial: High-Risk Inflammation (CCTT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01760902
First received: December 12, 2012
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

South Carolina has many gaps in health status of our citizens. Some of the biggest gaps are higher cancer rates among African Americans. The purpose of this study is to find people who have increased inflammation and study how well a community-based dietary and physical activity program works at reducing the risk of African Americans developing inflammation-related diseases.


Condition Intervention
Inflammation
Behavioral: Diet and Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diet & Activity Community Trial: High-Risk Inflammation

Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Change in C-Reactive Protein (CRP) levels from baseline to post intervention [ Time Frame: Baseline, Post Intervention (90) days) and 12 months beyond baseline ] [ Designated as safety issue: No ]
    Data are collected at three time points: baseline, 90 days from baseline, and 12 months (one year) from baseline. Evaluable data will be difference from 90 days from baseline or 12 months (one year) from baseline or both.


Secondary Outcome Measures:
  • Change in Interleukin 6 (IL6) values from baseline to either 90 days or 12 months or both. [ Time Frame: Baseline, Post intervention (90 days) and 12 months beyond baseline. ] [ Designated as safety issue: No ]
    As for the primary outcome measure, data are collected at three time points: baseline, 90 days from baseline, and 12 months (one year) from baseline. Evaluable data will be difference from 90 days from baseline or 12 months (one year) from baseline or both.

  • Change in body mass index (BMI) values from baseline to either 90 days or 12 months or both. [ Time Frame: Baseline, Post intervention (90 days) and 12 months beyond baseline. ] [ Designated as safety issue: No ]
    As for the primary outcome measure, data are collected at three time points: baseline, 90 days from baseline, and 12 months (one year) from baseline. Evaluable data will be difference from 90 days from baseline or 12 months (one year) from baseline or both.

  • Change in body fat mass (BFM) values from baseline to either 90 days or 12 months or both. [ Time Frame: Baseline, Post intervention (90 days) and 12 months beyond baseline. ] [ Designated as safety issue: No ]
    As for the primary outcome measure, data are collected at three time points: baseline, 90 days from baseline, and 12 months (one year) from baseline. Evaluable data will be difference from 90 days from baseline or 12 months (one year) from baseline or both.

  • Change in waist-to-hip ratio(WHR) values from baseline to either 90 days or 12 months or both. [ Time Frame: Baseline, Post intervention (90 days) and 12 months beyond baseline. ] [ Designated as safety issue: No ]
    As for the primary outcome measure, data are collected at three time points: baseline, 90 days from baseline, and 12 months (one year) from baseline. Evaluable data will be difference from 90 days from baseline or 12 months (one year) from baseline or both.

  • Change in mcp-1 values from baseline to either 90 days or 12 months or both. [ Time Frame: Baseline, Post intervention (90 days) and 12 months beyond baseline. ] [ Designated as safety issue: No ]
    As for the primary outcome measure, data are collected at three time points: baseline, 90 days from baseline, and 12 months (one year) from baseline. Evaluable data will be difference from 90 days from baseline or 12 months (one year) from baseline or both.


Estimated Enrollment: 418
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet and Physical Activity
Participants convene weekly for 12 consecutive weeks and then once per month for 9 months. Each sessions is 90 minutes
Behavioral: Diet and Physical Activity
The group will convene weekly for 12 consecutive weeks and monthly thereafter for 9 consecutive months. Thus, there will be a total of 21 group-based sessions over the one-year period

Detailed Description:

A diet and physical activity intervention was developed to provide knowledge and skills to facilitate health behavior change in African-American Baptist Church members in South Carolina and promote healthy lifestyles to reduce colon cancer disparities. The intervention entitled, "H.E.A.L.S. (Healthy Eating and Active Living in the Spirit)" was used to train church education teams to deliver church and community educational activities promoting a diet rich in fruits and vegetables and an active lifestyle. The training focused leadership and empowerment skills to enable church lay leaders to become Church Education Teams (CETs) . The educational activities made it easier for church and community members to eat more fruits and vegetables, reduce fat intake, increase physical activity, and increase dietary intake of anti-inflammatory foods associated with colon cancer risk.

This 12 week healthy eating and physical activity program is tailored to meet a church's needs and goals by:

  1. providing cooking classes, recipes,
  2. tips for increasing the level of physical activity in their daily routine
  3. assistance tracking basic measurements like

    • Weight
    • Blood pressure,
    • Inflammation levels

Education Goals:

  • Increase knowledge of health behavior and changes that can impact health status
  • Increase confidence in sharing health information with church, family, and community members.
  • Develop skills to facilitate behavior change
  • Develop skills to overcome barriers to behavior change
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American

Exclusion Criteria:

  • History of Cancer
  • History of Ulcerative colitis
  • Chrome Disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760902

Locations
United States, South Carolina
University of South Carolina (Columbia)
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Jmaes R. Hebert, ScD Universityof South Carolina
  More Information

No publications provided by University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01760902     History of Changes
Other Study ID Numbers: NIH5R24MD002769-02, 5R24MD002769-02
Study First Received: December 12, 2012
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
Inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014