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

Primary Purpose

Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral, Psychological or Informational Intervention
Behavioral, Psychological or Informational Intervention
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deleterious BRCA1 Gene Mutation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (DPP)

Group B (DPP-HT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
Changes in metabolic and breast cancer risk biomarkers
Biomarkers will be assessed through blood draws.
Changes in proposed behavioral mediators through survey
Eating patterns will be assessed through survey ASA24 (Automated Self-assessment).

Full Information

First Posted
May 14, 2018
Last Updated
September 14, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03546972
Brief Title
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
Official Title
Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2017 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ, Obesity, Overweight, Premalignant Lesion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (DPP)
Arm Type
Active Comparator
Arm Description
Participants take part in DPP once a week over 1 hour for 16 weeks.
Arm Title
Group B (DPP-HT)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Behavioral, Psychological or Informational Intervention
Intervention Description
Take part in DDP
Intervention Type
Other
Intervention Name(s)
Behavioral, Psychological or Informational Intervention
Intervention Description
Take part in HT
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate
Description
Measured by percentage of participants who enroll in the study.
Time Frame
Up to 2 years
Title
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates
Description
Measured by percentage of participants who leave the study.
Time Frame
Up to 2 years
Title
Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates
Description
Measured by percentage of participants who complete the study.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Changes in weight loss
Description
Will use linear regression to study the effects of participant characteristics (i.e., weight history) and their interactions with the treatment groups.
Time Frame
Baseline to 2 years
Title
Changes in metabolic and breast cancer risk biomarkers
Description
Biomarkers will be assessed through blood draws.
Time Frame
Baseline to 2 years
Title
Changes in proposed behavioral mediators through survey
Description
Eating patterns will be assessed through survey ASA24 (Automated Self-assessment).
Time Frame
At baseline and at 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Basen-Engquist
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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

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