Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants (NCT02154984) | Clinical Trial Compass
TerminatedNot Applicable
Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants
Stopped: Study closed due to funding before accrual was met
United States45 participantsStarted 2014-07
Plain-language summary
The purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer. The researchers would like to study whether a type of nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a smartphone application; the researchers also want to study the effect that a tRD has on weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to restrict their daily eating to a specific time frame each day. The researchers think that this might be an effective and manageable way to control weight.
Who can participate
Age range
18 Years – 65 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:
* Subjects must have a stable weight (have not gained or lost 25 pounds in the last 6 months)
* Subjects must have had a normal mammogram within 9 months prior to registration; NOTE: subjects must also have a normal breast exam on the day of the pre-intervention random fine needle aspiration (rFNA)
* Subjects must have a body mass index (BMI) of 25-40
* Subjects must fit into ONE of the following menopausal categories:
* Premenopausal (n = 40) - defined as meeting all the following criteria:
* Have had at least 8 menstrual cycles in the past 12 months
* Have had no hormonal contraception in the past 3 months prior to registration
* Have serum hormone parameters (estradiol \[E2\], progesterone, follicle stimulating hormone \[FSH\]) in premenopausal range on the day of rFNA; NOTE: subjects will self-report menopausal status at registration, and confirmation of hormonal parameters will occur after registration as part of pre-intervention procedures; if there is mis-assignment of status, the recruitment of future subjects will be adjusted accordingly
* Postmenopausal (n = 40) - defined as meeting all of the following criteria:
* Last menstrual period (LMP) \> 1 year previously
* Have had no hormone use in the past 3 months prior to registration
* Serum E2, progesterone, FSH in postmenopausal range on the day of rFNA; NOTE: subjects will self-report menopausal status at registration, and confirmation of hormonal parameters will o…
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
Adherence to self-monitoring
Timeframe: Up to 3 months after completion of study
2
Attaining the goal of dietary time restriction
Timeframe: Up to 3 months after completion of study