Clinical trial NCT01760902: Diet & Activity Community Trial: High-Risk Inflammation
Official title: Diet & Activity Community Trial: High-Risk Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Inflammation
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Institutes of Health (NIH)
First posted: 2013-01-04
Enrollment: 438
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* African American

Exclusion Criteria:

* History of Cancer
* History of Ulcerative colitis
* Chrome Disease

Primary outcomes:
measure: Change in C-Reactive Protein (CRP) levels from baseline to post intervention
timeFrame: Baseline, Post Intervention (90) days) and 12 months beyond baseline
Secondary outcomes:
measure: Change in Interleukin 6 (IL6) values from baseline to either 90 days or 12 months or both.
timeFrame: Baseline, Post intervention (90 days) and 12 months beyond baseline.
measure: Change in body mass index (BMI) values from baseline to either 90 days or 12 months or both.
timeFrame: Baseline, Post intervention (90 days) and 12 months beyond baseline.
measure: Change in body fat mass (BFM) values from baseline to either 90 days or 12 months or both.
timeFrame: Baseline, Post intervention (90 days) and 12 months beyond baseline.
measure: Change in waist-to-hip ratio(WHR) values from baseline to either 90 days or 12 months or both.
timeFrame: Baseline, Post intervention (90 days) and 12 months beyond baseline.
measure: Change in mcp-1 values from baseline to either 90 days or 12 months or both.
timeFrame: Baseline, Post intervention (90 days) and 12 months beyond baseline.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina (Columbia)
state: South Carolina
Study officials:
affiliation: Universityof South Carolina
name: Jmaes R. Hebert, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.