NCT03546972

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Deleterious BRCA1 Gene Mutation
• Deleterious BRCA2 Gene Mutation
• Ductal Breast Carcinoma In Situ
• Obesity
• Overweight
• Premalignant Lesion

Interventions

Type	Name	Description
OTHER	Behavioral, Psychological or Informational Intervention	Take part in DDP
OTHER	Behavioral, Psychological or Informational Intervention	Take part in HT
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-12-17
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2018-06-06
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States