Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01760902
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
James hebert, University of South Carolina

Tracking Information
First Submitted Date  ICMJE December 12, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date April 18, 2019
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
Change in C-Reactive Protein (CRP) levels from baseline to post intervention [ Time Frame: Baseline, Post Intervention (90) days) and 12 months beyond baseline ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • 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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet & Activity Community Trial: High-Risk Inflammation
Official Title  ICMJE Diet & Activity Community Trial: High-Risk Inflammation
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:

  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Inflammation
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Behavioral: Diet and Physical Activity
Publications * Hébert 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2015)
438
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
418
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • African American

Exclusion Criteria:

  • History of Cancer
  • History of Ulcerative colitis
  • Chrome Disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760902
Other Study ID Numbers  ICMJE Pro00001881
5R24MD002769-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James hebert, University of South Carolina
Study Sponsor  ICMJE University of South Carolina
Collaborators  ICMJE
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Jmaes R. Hebert, ScD Universityof South Carolina
PRS Account University of South Carolina
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP