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Deleterious BRCA1 Gene MutationNCT03546972

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

A study testing Behavioral, Psychological or Informational Intervention and Questionnaire Administration in people with Deleterious BRCA1 Gene Mutation and Deleterious BRCA2 Gene Mutation, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 70 years, women onlyHealthy volunteers can take part
What is being tested?
Behavioral, Psychological or Informational Intervention and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
17 Dec 2017to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the feasibility of adding hunger training to the Diabetes Prevention Program (DPP) using the following criteria: accrual rates > 50%, attrition rates < 20% and, in the DPP-plus-hunger training (HT) group, training protocol adherence rates > 75%.

SECONDARY OBJECTIVES:

  1. Estimate the magnitude of effect sizes and variation in outcome variables for the DPP-only and DPP-plus-HT interventions on changes in weight; in metabolic and breast cancer risk biomarkers (e.g., fasting insulin and blood glucose [BG] levels, levels of glycosylated hemoglobin, insulin resistance, adiponectin, interleukin-6, and C-reactive protein); and in proposed behavioral mediators (e.g., reduction in total energy intake, overall eating frequency, percent of eating events occurring at or below the average fasting blood BG level).

II. Examine the mediation effects of proposed mechanisms of the interventions related to individual-level behavioral measures of eating self-regulation on the proposed outcomes using a multimodal approach of validated questionnaires and reliable ecological momentary assessment method.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP A: Participants take part in DPP once a week over 1 hour for 16 weeks.

GROUP B: Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.

Being tested
Behavioral, Psychological or Informational Intervention, Questionnaire Administration
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral, Psychological or Informational InterventionOther

    Take part in DDP

  • Behavioral, Psychological or Informational InterventionOther

    Take part in HT

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03546972
Study groupRoleWhat they receive
Group A (DPP)Active comparatorParticipants take part in DPP once a week over 1 hour for 16 weeks.
Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration
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.
Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. 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.

    Measured: Baseline to 2 years

  2. Changes in metabolic and breast cancer risk biomarkers

    Biomarkers will be assessed through blood draws.

    Measured: Baseline to 2 years

  3. Changes in proposed behavioral mediators through survey

    Eating patterns will be assessed through survey ASA24 (Automated Self-assessment).

    Measured: At baseline and at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start17 Dec 2017
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03546972
Sponsor's protocol ID
2017-0507
Other IDs
NCI-2018-01275, 2017-0507, R21CA215415
Status last verified
Oct 2026
First submitted
14 May 2018
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38660060

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral, Psychological or Informational Intervention and Questionnaire Administration in people with Deleterious BRCA1 Gene Mutation and Deleterious BRCA2 Gene Mutation, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03546972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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