Sistas Inspiring Sistas Through Activity and Support (SISTAS)

SCCDCN-II: Research Project (Breast Cancer)

It is known that diet and physical affect a variety of disease-related endpoints and overall health status in general. The investigators also know that dietary and PA intervention effects are difficult for individuals to maintain. By contrast, the investigators have some evidence that group-based and family-centered, multi-component interventions are more effective in terms of creating large changes in diet-related outcomes. Using a group-randomized, controlled design, the overall goal of this project is to reduce breast cancer-related health disparities in a high-risk community, by achieving these Primary Aims,to conduct a regionally-based community-designed dietary and physical activity behavioral controlled trial among AA women,to test the effectiveness of the community-designed, family-based dietary and physical activity behavioral intervention on modifying biomarkers of inflammation and to test the effectiveness of the community-designed, family-based dietary and physical activity behavioral intervention on decreasing breast density

Study Overview

• Status: Completed
• Conditions: Prevention Harmful Effects
• Intervention / Treatment: Behavioral: Lifestyle

Detailed Description

AAs in South Carolina bear an unequal burden of cancer incidence and mortality compared to their European American counterparts. The Research Program (RP) is committed to investigating and eliminating this burden through the careful conduct of research studies in partnership with their AA community partners. The overall aim of the RP is to support the SCCDCN-II in its mission to reduce, and ultimately eliminate, cancer health disparities using a community-based participatory research (CBPR) approach to design and conduct research projects in AA communities in South Carolina. The goals of the research program are to: support the SCCDCN by serving as a research liaison/consultant for all community-based activities; foster and support meaningful partnerships between academic researchers and community leaders and representatives; conduct a two-arm physical activity and dietary intervention trial for breast cancer prevention among African-American women in the investigators target communities of faith; conduct a pilot study to determine African-American men's and women's knowledge about prostate cancer screening and their knowledge and attitudes regarding participation in prostate cancer research, including National Cancer Institute (NCI) sponsored clinical trials; support additional research in cancer disparities through a Pilot Study post-transition year and to develop and implement an SCCDCN-II internal pilot grants program in years 4 and 5; and partner with community representatives to disseminate program findings and to work with colleagues in the AC, and Community Outreach and Training Programs to develop community capacity aimed at sustaining programs to improve health The two-arm intervention trial will be aimed at testing the effectiveness of a community-designed, family-based dietary and PA behavioral intervention on modifying biomarkers of inflammation and decreasing breast density with a randomized controlled design. The prostate cancer pilot will be aimed at assessing current knowledge and attitudes regarding prostate cancer prevention and screening, and participation in prostate cancer research; changes in knowledge and attitudes about research participation following a pilot education program; and culturally appropriate strategies for promoting cancer research among AAs in a faith-based community. All activities of the research program will be conducted in partnership with identified SCCDCN II community partners, the State Baptist YWA of the Women's BEMC, SCPHCA, CCBHSN, and Insights Consulting. It is anticipated that research activities will be conducted in all 5 years of the granting period with opportunities for research partnerships in all State Baptist YWA regions throughout the state.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 30 years of age or older
• African American
• BMI 30 or<
• Willing to be randomized,

Exclusion Criteria:

• History of cancer
• Inflammatory-related conditions
• Unstable hormones replacement treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle; Diet and physical activity intervention group. Measurements taken at baseline, 12 weeks and 1 year.	Behavioral: Lifestyle; Participants are consented and randomized into the intervention group or delayed intervention group(intervention offered one year later). Participants in intervention group attend 12 weekly sessions and 9 monthly sessions. All participants attend 3 clinics in which we collect data, measurements and blood samples. These clinics occur at baseline, 12 weeks and one year.; Other Names: SISTAS
No Intervention: Wait-list control; No-treatment control group. Measurements taken at baseline, 12 weeks and 1 year. People in the control condition can elect to take the intervention after 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Response	This will entail examining changes in the inflammatory index derived from dietary self-report and self-reported physical activity and blood samples.	Baseline, 12 weeks and 12 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Investigators: Study Director: Swann Arp-Adams, Ph.D, University of South Carolina

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pro00008713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be made available upon request using our data request form and with data committee approval. We will allow the data to be shared after publication of our two primary outcome manuscripts.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No