Diet & Activity Community Trial: High-Risk Inflammation

NCT ID: NCT01760902

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-03-31

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

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diet and Physical Activity

Participants convene weekly for 12 consecutive weeks and then once per month for 9 months. Each sessions is 90 minutes

Group Type: EXPERIMENTAL

Diet and Physical Activity

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• African American

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

James hebert

James R. Hebert, MSPH, ScD, Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jmaes R. Hebert, ScD

Role: PRINCIPAL_INVESTIGATOR

Universityof South Carolina

Locations

University of South Carolina (Columbia)

Columbia, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24050419 (View on PubMed)

Other Identifiers

5R24MD002769-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00001881

Identifier Type: -

Identifier Source: org_study_id