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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Overweight; Ductal Breast Carcinoma In Situ; Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Premalignant Lesion
• Intervention / Treatment: Other: Questionnaire Administration; Other: Behavioral, Psychological or Informational Intervention; Other: Behavioral, Psychological or Informational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (DPP); Participants take part in DPP once a week over 1 hour for 16 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Behavioral, Psychological or Informational Intervention; Take part in DDP; Other: Behavioral, Psychological or Informational Intervention; Take part in HT
Experimental: Group B (DPP-HT); Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.	Other: Questionnaire Administration; Ancillary studies; Other: Behavioral, Psychological or Informational Intervention; Take part in DDP; Other: Behavioral, Psychological or Informational Intervention; Take part in HT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in metabolic and breast cancer risk biomarkers	Biomarkers will be assessed through blood draws.	Baseline to 2 years
Changes in proposed behavioral mediators through survey	Eating patterns will be assessed through survey ASA24 (Automated Self-assessment).	At baseline and at 16 weeks

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen M Basen-Engquist, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2017
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Overnutrition; Nutrition Disorders; Body Weight; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Carcinoma in Situ; Breast Neoplasms; Overweight; Breast Carcinoma In Situ; Precancerous Conditions; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
• Other Study ID Numbers: 2017-0507 (Other Identifier: M D Anderson Cancer Center); NCI-2018-01275 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA215415 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No