NCT01760902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

December 12, 2012

Last Update Submit

April 16, 2019

Conditions

Inflammation

Keywords

Inflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (1)

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

Behavioral: Diet and Physical Activity

Interventions

Diet and Physical ActivityBEHAVIORAL

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

Diet and Physical Activity

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina (Columbia)

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

  • 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.

    PMID: 24050419DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jmaes R. Hebert, ScD

    Universityof South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
James R. Hebert, MSPH, ScD, Director

Study Record Dates

First Submitted

December 12, 2012

First Posted

January 4, 2013

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

US(1)