Communication & Peer Support Effects on Physical Activity in Overweight Postmenopausal Women (NCT01940016) | Clinical Trial Compass
CompletedNot Applicable
Communication & Peer Support Effects on Physical Activity in Overweight Postmenopausal Women
United States71 participantsStarted 2007-04-01
Plain-language summary
This randomized clinical trial studies the feasibility of tailored physical activity intervention that is administered using Interactive Voice Response technology and cell phones. Interactive voice response and health coach support may motivate overweight postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast cancer.
Who can participate
Age range
55 Years – 75 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:
* Present a letter/documentation from a primary physician stating that they can participate in a physical activity program that will require walking up to 10,000 steps per day
* Have a body mass index (BMI) between 25 and 40 kg/m\^2 (inclusive)
* Be postmenopausal, defined as no period for 12 months if over age 55, or no period for 12 months; also, women who have had their ovaries removed will be considered as postmenopausal
* Willing to participate in a wellness program that lasts 12 weeks and involves walking for at least 30 minutes a day on most days
* Has access to a cell phone during the 12-week intervention
* Functional knowledge of English (ability to both read and write)
Exclusion Criteria:
* Taking hormone replacement therapy within 3 months of enrollment
* Taking Tamoxifen or Raloxifene within 3 months of enrollment
* Enrolled in a weight management program, such as Weight Watchers
* Engaged in regular, planned walking of at least 30 minutes a day
* Previous history of breast cancer
* Premenopausal
* Age \> 75 years, to minimize co-morbidities
* Cannot walk one mile
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Change in time taken to complete a one mile walk.
Timeframe: 12 weeks
Trial details
NCT IDNCT01940016
SponsorOhio State University Comprehensive Cancer Center