InflammationCCTTNCT01760902
Diet & Activity Community Trial: High-Risk Inflammation
A study testing Diet and Physical Activity in people with Inflammation, run by University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Diet and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
Who cannot join
- History of Cancer
- History of Ulcerative colitis
- Chrome Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina (Columbia)
Columbia, South Carolina, 29208
About this study
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.
Read the 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:
- 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
- Conditions
- Inflammation
- Being tested
- Diet and Physical Activity
- Keywords
- Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and Physical ActivityBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Diet and Physical Activity | Experimental | Participants convene weekly for 12 consecutive weeks and then once per month for 9 months. Each sessions is 90 minutes Receives: Behavioral: Diet and Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post Intervention (90) days) and 12 months beyond baseline
Secondary outcomes (5)
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.
Measured: Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.
Measured: Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.
Measured: Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.
Measured: Baseline, Post intervention (90 days) and 12 months beyond baseline.
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.
Measured: Baseline, Post intervention (90 days) and 12 months beyond baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, James hebert, University of South Carolina
- Investigators
- Jmaes R. Hebert, ScD, Principal investigator, Universityof South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760902
- Sponsor's protocol ID
- Pro00001881
- Other IDs
- 5R24MD002769-02
- Acronym
- CCTT
- Status last verified
- Apr 2019
- First submitted
- 12 Dec 2012
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24050419
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet & Activity Community Trial: High-Risk Inflammation
- ClinicalTrials.gov ID
- NCT01760902
- Acronym / sponsor ID
- CCTT / Pro00001881
- Conditions
- Inflammation
- Keywords
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet and Physical Activity | Experimental | Behavioral: Diet and Physical ActivityParticipants convene weekly for 12 consecutive weeks and then once per month for 9 months. Each sessions is 90 minutes |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African American
Key exclusion criteria (3 listed)
- History of Cancer
- History of Ulcerative colitis
- Chrome Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and Physical ActivityThe 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 | Behavioural | Diet and Physical Activity |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 24050419Hebert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jmaes R. Hebert, ScD principal investigator
Universityof South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Physical Activity in people with Inflammation, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-Reactive Protein (CRP) levels from baseline to post intervention (time frame: Baseline, Post Intervention (90) days) and 12 months beyond baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.