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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Overweight; Obesity; Deleterious BRCA1 Gene Mutation; Ductal Breast Carcinoma In Situ; Deleterious BRCA2 Gene Mutation; Premalignant Lesion

Treatments: Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03546972

R21CA215415 (U.S. NIH Grant/Contract)

NCI-2018-01275 (Registry Identifier)

2017-0507 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Group A (DPP)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Behavioral, Psychological or Informational Intervention

Other: Behavioral, Psychological or Informational Intervention

Group B (DPP-HT)

Experimental group

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.

Treatment:

Other: Questionnaire Administration

Other: Behavioral, Psychological or Informational Intervention

Other: Behavioral, Psychological or Informational Intervention