Diet & Activity Community Trial: High-Risk Inflammation

Inflammation Clinical Trial

— CCTT  

Official title:

Diet & Activity Community Trial: High-Risk Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760902
• Other study ID #: Pro00001881
• Secondary ID: 5R24MD002769-02
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2019
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• African American

Exclusion Criteria:

• History of Cancer

• History of Ulcerative colitis

• Chrome Disease

Related Conditions & MeSH terms

• Inflammation

Intervention

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

Locations

Country	Name	City	State
United States	University of South Carolina (Columbia)	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.