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Completed

NCT Number: NCT01760902

Diet & Activity Community Trial: High-Risk Inflammation

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina (Columbia)

Columbia, South Carolina, 29208, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • African American

Exclusion criteria

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

Treatment and study plan

Diet and physical activity

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

Primary outcomes

  1. Change in C-Reactive Protein (CRP) levels from baseline to post intervention

    Time frame: Baseline, Post Intervention (90) days) and 12 months beyond baseline

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Institutes of Health (NIH)

Registry information

Acronym: CCTT

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jan 4, 2013
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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