Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deleterious BRCA1 Gene Mutation | — | UNRESOLVED | — |
| Deleterious BRCA2 Gene Mutation | — | UNRESOLVED | — |
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
| Premalignant Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A (DPP)
- description
- Participants take part in DPP once a week over 1 hour for 16 weeks.
- interventionNames
- Other: Behavioral, Psychological or Informational Intervention
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Group B (DPP-HT)
- description
- Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.
- interventionNames
- Other: Behavioral, Psychological or Informational Intervention
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJospe 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 38660060