Diet & Activity Community Trial: High-Risk Inflammation (CCTT)
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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 |
- 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.
- 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: | September 2013 |
| Estimated 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:
- 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
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- African American
Exclusion Criteria:
- History of Cancer
- History of Ulcerative colitis
- Chrome Disease
Contacts and Locations| United States, South Carolina | |
| University of South Carolina (Columbia) | |
| Columbia, South Carolina, United States, 29208 | |
| Principal Investigator: | Jmaes R. Hebert, ScD | Universityof South Carolina |
More Information
No publications provided
| 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, 2013 |
| 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 May 23, 2013