Obesity Clinical Trial
Official title:
Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise
Verified date | March 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 51 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate | Measured by percentage of participants who enroll in the study. | Up to 2 years | |
Primary | Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates | Measured by percentage of participants who leave the study. | Up to 2 years | |
Primary | Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates | Measured by percentage of participants who complete the study. | Up to 2 years | |
Secondary | Changes in weight loss | Will use linear regression to study the effects of participant characteristics (i.e., weight history) and their interactions with the treatment groups. | Baseline to 2 years | |
Secondary | Changes in metabolic and breast cancer risk biomarkers | Biomarkers will be assessed through blood draws. | Baseline to 2 years | |
Secondary | Changes in proposed behavioral mediators through survey | Eating patterns will be assessed through survey ASA24 (Automated Self-assessment). | At baseline and at 16 weeks |
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