Sistas Inspiring Sistas Through Activity and Support

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

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Key information

Conditions

Prevention Harmful Effects

Age range

30 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lifestyle

Behavioral

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

Primary outcomes

Inflammatory Response

Time frame: Baseline, 12 weeks and 12 months

This will entail examining changes in the inflammatory index derived from dietary self-report and self-reported physical activity and blood samples.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

SCCDCN-II: Research Project (Breast Cancer)

Acronym: SISTAS

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: May 22, 2014
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.

Published trials that share one or more normalized conditions with this study.

Completed