Introduction: Recruiting racial, ethnic, and other underserved minorities into conventional clinic-based and other trials is known to be challenging. The Sistas Inspiring Sistas Through Activity and Support (SISTAS) Program was a one-year randomized controlled trial (RCT) to promote physical activity and healthy eating among AA women in SC to reduce inflammatory biomarkers, which are linked to increased breast cancer (BrCa) risk and mortality. This study describes the development, recruitment, and implementation of the SISTAS clinical trial and provides baseline characteristics of the study participants. Methods: SISTAS was developed using community-based participatory research (CBPR) approaches. At baseline, study participants completed assessments and underwent clinical measurements and blood draws to measure C-reactive protein (CRP) and interleukin-6 (IL-6). Participants randomized to the intervention received 12 weekly classes followed by nine monthly booster sessions. Post-intervention measurements were assessed at 12-week and 12-month follow-ups. Results: We recruited a total of 337 women who tended to: be middle-aged (mean age 48.2 years); have some college education; be employed full-time; have Medicare as their primary insurance; be non-smokers; and perceive their personal health as good. On average, the women were pre-hypertensive at baseline (mean systolic blood pressure = 133.9 mm Hg; mean diastolic blood pressure = 84.0 mm Hg) and morbidly obese (mean BMI >40.0 kg/m2); the mean fat mass and fat-free mass among participants were 106.4 lb and 121.0 lb, respectively. Conclusion: The SISTAS RCT addresses some of the gaps in the literature with respect to CBPR interventions targeting AA women, such as implementing diet and physical activity in CBPR-based studies to decrease BrCa risk.
RCT Entities:
Introduction: Recruiting racial, ethnic, and other underserved minorities into conventional clinic-based and other trials is known to be challenging. The Sistas Inspiring Sistas Through Activity and Support (SISTAS) Program was a one-year randomized controlled trial (RCT) to promote physical activity and healthy eating among AA women in SC to reduce inflammatory biomarkers, which are linked to increased breast cancer (BrCa) risk and mortality. This study describes the development, recruitment, and implementation of the SISTAS clinical trial and provides baseline characteristics of the study participants. Methods: SISTAS was developed using community-based participatory research (CBPR) approaches. At baseline, study participants completed assessments and underwent clinical measurements and blood draws to measure C-reactive protein (CRP) and interleukin-6 (IL-6). Participants randomized to the intervention received 12 weekly classes followed by nine monthly booster sessions. Post-intervention measurements were assessed at 12-week and 12-month follow-ups. Results: We recruited a total of 337 women who tended to: be middle-aged (mean age 48.2 years); have some college education; be employed full-time; have Medicare as their primary insurance; be non-smokers; and perceive their personal health as good. On average, the women were pre-hypertensive at baseline (mean systolic blood pressure = 133.9 mm Hg; mean diastolic blood pressure = 84.0 mm Hg) and morbidly obese (mean BMI >40.0 kg/m2); the mean fat mass and fat-free mass among participants were 106.4 lb and 121.0 lb, respectively. Conclusion: The SISTAS RCT addresses some of the gaps in the literature with respect to CBPR interventions targeting AA women, such as implementing diet and physical activity in CBPR-based studies to decrease BrCa risk.
Authors: James R Hébert; Michael Wirth; Lisa Davis; Briana Davis; Brook E Harmon; Thomas G Hurley; Ruby Drayton; E Angela Murphy; Nitin Shivappa; Sara Wilcox; Swann A Adams; Heather M Brandt; Christine E Blake; Cheryl A Armstead; Susan E Steck; Steven N Blair Journal: Am J Prev Med Date: 2013-10 Impact factor: 5.043
Authors: Michael D Wirth; James Burch; Nitin Shivappa; John M Violanti; Cecil M Burchfiel; Desta Fekedulegn; Michael E Andrew; Tara A Hartley; Diane B Miller; Anna Mnatsakanova; Luenda E Charles; Susan E Steck; Thomas G Hurley; John E Vena; James R Hébert Journal: J Occup Environ Med Date: 2014-09 Impact factor: 2.162
Authors: Nitin Shivappa; Susan E Steck; Thomas G Hurley; James R Hussey; Yunsheng Ma; Ira S Ockene; Fred Tabung; James R Hébert Journal: Public Health Nutr Date: 2013-10-10 Impact factor: 4.022
Authors: Samantha C Truman; Michael D Wirth; Swann Arp Adams; Gabrielle M Turner-McGrievy; Kelly E Reiss; James R Hébert Journal: Chronobiol Int Date: 2022-04-05 Impact factor: 3.749
Authors: Oluwole Adeyemi Babatunde; Swann Arp Adams; Samantha Truman; Erica Sercy; Angela E Murphy; Samira Khan; Thomas G Hurley; Michael D Wirth; Seul Ki Choi; Hiluv Johnson; James R Hebert Journal: Women Health Date: 2020-04-05
Authors: Susan E McCann; Elisa M Rodriguez; Deborah Erwin; Song Yao; David Tritchler; Meredith A J Hullar; Tracey O'Connor; Johanna W Lampe Journal: Curr Dev Nutr Date: 2022-01-29