Clinical trial

Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03546972

Active, not recruitingNot applicableInterventional

What this study is about

This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 70 Years
SexFemale
Healthy volunteersAccepted
ConditionDeleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ, Obesity, Overweight, Premalignant Lesion

Full registry criteria

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.

Treatments and study arms

Behavioral, Psychological or Informational Intervention

Other

Take part in DDP

Behavioral, Psychological or Informational Intervention

Other

Take part in HT

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rateUp to 2 years

Measured by percentage of participants who enroll in the study.

Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out ratesUp to 2 years

Measured by percentage of participants who leave the study.

Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion ratesUp to 2 years

Measured by percentage of participants who complete the study.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

M D Anderson Cancer Center🇺🇸 Houston, Texas, United States