Diet & Activity Community Trial: High-Risk Inflammation (CCTT)
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet and Physical Activity
Sponsored by

About this trial
This is an interventional prevention trial for Inflammation focused on measuring Inflammation
Eligibility Criteria
Inclusion Criteria:
- African American
Exclusion Criteria:
- History of Cancer
- History of Ulcerative colitis
- Chrome Disease
Sites / Locations
- University of South Carolina (Columbia)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diet and Physical Activity
Arm Description
Participants convene weekly for 12 consecutive weeks and then once per month for 9 months. Each sessions is 90 minutes
Outcomes
Primary Outcome Measures
Change in C-Reactive Protein (CRP) levels from baseline to post intervention
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01760902
First Posted
December 12, 2012
Last Updated
April 16, 2019
Sponsor
University of South Carolina
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT01760902
Brief Title
Diet & Activity Community Trial: High-Risk Inflammation
Acronym
CCTT
Official Title
Diet & Activity Community Trial: High-Risk Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
providing cooking classes, recipes,
tips for increasing the level of physical activity in their daily routine
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet and Physical Activity
Arm Type
Experimental
Arm Description
Participants convene weekly for 12 consecutive weeks and then once per month for 9 months. Each sessions is 90 minutes
Intervention Type
Behavioral
Intervention Name(s)
Diet and Physical Activity
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in C-Reactive Protein (CRP) levels from baseline to post intervention
Description
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.
Time Frame
Baseline, Post Intervention (90) days) and 12 months beyond baseline
Secondary Outcome Measure Information:
Title
Change in Interleukin 6 (IL6) values from baseline to either 90 days or 12 months or both.
Description
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.
Time Frame
Baseline, Post intervention (90 days) and 12 months beyond baseline.
Title
Change in body mass index (BMI) values from baseline to either 90 days or 12 months or both.
Description
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.
Time Frame
Baseline, Post intervention (90 days) and 12 months beyond baseline.
Title
Change in body fat mass (BFM) values from baseline to either 90 days or 12 months or both.
Description
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.
Time Frame
Baseline, Post intervention (90 days) and 12 months beyond baseline.
Title
Change in waist-to-hip ratio(WHR) values from baseline to either 90 days or 12 months or both.
Description
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.
Time Frame
Baseline, Post intervention (90 days) and 12 months beyond baseline.
Title
Change in mcp-1 values from baseline to either 90 days or 12 months or both.
Description
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.
Time Frame
Baseline, Post intervention (90 days) and 12 months beyond baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
African American
Exclusion Criteria:
History of Cancer
History of Ulcerative colitis
Chrome Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jmaes R. Hebert, ScD
Organizational Affiliation
Universityof South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina (Columbia)
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24050419
Citation
Hebert JR, Wirth M, Davis L, Davis B, Harmon BE, Hurley TG, Drayton R, Angela Murphy E, Shivappa N, Wilcox S, Adams SA, Brandt HM, Blake CE, Armstead CA, Steck SE, Blair SN. C-reactive protein levels in African Americans: a diet and lifestyle randomized community trial. Am J Prev Med. 2013 Oct;45(4):430-40. doi: 10.1016/j.amepre.2013.05.011.
Results Reference
derived
Learn more about this trial
Diet & Activity Community Trial: High-Risk Inflammation
We'll reach out to this number within 24 hrs