Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise
3 other identifiers
interventional
51
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2017
CompletedFirst Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
April 15, 2026
April 1, 2026
9 years
May 14, 2018
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (3)
Changes in weight loss
Baseline to 2 years
Changes in metabolic and breast cancer risk biomarkers
Baseline to 2 years
Changes in proposed behavioral mediators through survey
At baseline and at 16 weeks
Study Arms (2)
Group A (DPP)
ACTIVE COMPARATORParticipants take part in DPP once a week over 1 hour for 16 weeks.
Group B (DPP-HT)
EXPERIMENTALParticipants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.
Interventions
Take part in DDP
Eligibility Criteria
You may qualify if:
- 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.
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Jospe MR, Liao Y, Giles ED, Hudson BI, Slingerland JM, Schembre SM. A low-glucose eating pattern is associated with improvements in glycemic variability among women at risk for postmenopausal breast cancer: an exploratory analysis. Front Nutr. 2024 Apr 10;11:1301427. doi: 10.3389/fnut.2024.1301427. eCollection 2024.
PMID: 38660060DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen M Basen-Engquist
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
June 6, 2018
Study Start
December 17, 2017
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04