Hunger training may help cut breast cancer risk in obese women
NCT ID NCT03546972
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study looks at whether adding hunger training to a standard diabetes prevention program helps obese women at high risk for breast cancer lose weight and lower their cancer risk. About 51 participants will learn weight-loss strategies and how to recognize true hunger. The main goal is to see if this approach is practical and effective.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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51 people
The number who actually took part.
- Started
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Dec 2017
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Body Mass Index (BMI) \>= 27 kg/m\^2. * At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk \> 20% or a 5 year risk \>1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion. * 12 months without a period/menstrual cycle or having had a bilateral oophorectomy. * Ability to take digital time stamped photos. * Internet access (daily). * Reports being proficient in English (can read/write and speak fluently). Exclusion Criteria: * Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible. * Has a current measured BMI less than 27 kg/m\^2. * Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks. * Currently being actively treated for cancer other than nonmelanoma skin cancer. * Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests. * Reported current diagnosis or history of type I diabetes or type 2 diabetes. * Reported use of oral antidiabetic agents (OADs). * Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids). * Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator). * Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide, liraglutide). * Fasting blood glucose level \> 126 and glycosylated hemoglobin (HbA1c) \> 7%. * Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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