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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
51
Take part in DDP
Take part in HT
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years
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.
Time frame: Baseline to 2 years
Changes in metabolic and breast cancer risk biomarkers
Biomarkers will be assessed through blood draws.
Time frame: Baseline to 2 years
Changes in proposed behavioral mediators through survey
Eating patterns will be assessed through survey ASA24 (Automated Self-assessment).
Time frame: At baseline and at 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.