Clinical trial NCT03546972: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Deleterious BRCA1 Gene Mutation
Deleterious BRCA2 Gene Mutation
Ductal Breast Carcinoma In Situ
Obesity
Overweight
Premalignant Lesion
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-06-06
Enrollment: 51
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate
timeFrame: Up to 2 years
measure: Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates
timeFrame: Up to 2 years
measure: Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates
timeFrame: Up to 2 years
Secondary outcomes:
measure: Changes in weight loss
timeFrame: Baseline to 2 years
measure: Changes in metabolic and breast cancer risk biomarkers
timeFrame: Baseline to 2 years
measure: Changes in proposed behavioral mediators through survey
timeFrame: At baseline and at 16 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen M Basen-Engquist
role: PRINCIPAL_INVESTIGATOR
References: