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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Behavioral: Diet and Physical Activity

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: Interventional
• Enrollment (Actual): 438
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina (Columbia)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• African American

Exclusion Criteria:

• History of Cancer
• History of Ulcerative colitis
• Chrome Disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Post Intervention (90) days) and 12 months beyond baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.	Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.	Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.	Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.	Baseline, Post intervention (90 days) and 12 months beyond baseline.

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jmaes R. Hebert, ScD, Universityof South Carolina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Pro00001881; 5R24MD002769-02 (U.S. NIH Grant/Contract)