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Diet & Activity Community Trial: High-Risk Inflammation

Diet & Activity Community Trial: High-Risk Inflammation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01760902
Acronym
CCTT
Enrollment
438
Registered
2013-01-04
Start date
2010-03-31
Completion date
2014-03-31
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

Inflammation

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

Interventions

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

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* African American

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in C-Reactive Protein (CRP) levels from baseline to post interventionBaseline, Post Intervention (90) days) and 12 months beyond baselineData 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

MeasureTime frameDescription
Change in Interleukin 6 (IL6) values from baseline to either 90 days or 12 months or both.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.
Change in body mass index (BMI) values from baseline to either 90 days or 12 months or both.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.
Change in body fat mass (BFM) values from baseline to either 90 days or 12 months or both.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.
Change in waist-to-hip ratio(WHR) values from baseline to either 90 days or 12 months or both.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.
Change in mcp-1 values from baseline to either 90 days or 12 months or both.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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026