Diet & Activity Community Trial: High-Risk Inflammation

Study Overview
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Brief Summary
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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
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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

Official Title
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Diet & Activity Community Trial: High-Risk Inflammation

Conditions
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Inflammation

Intervention / Treatment
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* Behavioral: Diet and Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American Exclusion Criteria: History of Cancer History of Ulcerative colitis Chrome Disease

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet and Physical Activity<br>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<br>* 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<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation