Sistas Inspiring Sistas Through Activity and Support (NCT02144571) | Clinical Trial Compass
CompletedNot Applicable
Sistas Inspiring Sistas Through Activity and Support
United States350 participantsStarted 2010-11
Plain-language summary
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
Who can participate
Age range
30 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on inflammatory response as a primary outcome — can you explain how inflammation connects to my specific condition, and whether reducing it through activity and peer support is something worth prioritizing in my care plan?
2The trial name suggests it was designed specifically for women and centered on social support alongside physical activity — given my background and lifestyle, do you think that kind of community-based approach could realistically work for me compared to other prevention strategies you might recommend?
3Since this study is listed under 'prevention of harmful effects' and has already been completed, have the results been published, and if so, what did they actually find about whether the activity and support program made a meaningful difference in inflammation markers?
4Because this trial is listed as Phase NA — meaning it wasn't a traditional drug trial with standard phase safety testing — how does that affect what we can reliably conclude about the safety and effectiveness of this type of intervention for someone in my situation?
5Now that this trial is completed, are there follow-up studies or similar programs currently available that I could actually participate in, or would standard care recommendations be a better starting point for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.