Early Stage Breast Cancer Participants can Make Significant Reductions in Dietary Fat Intake: Evidence From The Women's Intervention Nutrition Study (Wins)

Abstract

LEARNING OUTCOME: To comprehend the logistics and success of nutrition intervention in a large, multi-centered clinical trial. WINS is a NCI sponsored multi-center randomized trial testing the hypothesis that dietary fat intake reduction as a component of standard adjuvant breast cancer therapy (tamoxifen + defined Chemo Rx) will reduce recurrence and increase survival for women with localized breast cancer. Currently over 1,000 women of a target of 2,500 (≥48 to ≤ 78 years), from 34 participating clinics have been randomized to either the intervention group (IIG) (target of 15% energy from fat) or the non-intervention group (NIG). The intervention is initially provided in a series of eight one on one counseling sessions with a Registered Dietitian over a four month period. Social and behavioral theories are incorporated to promote dietary change and long-term adherence through individualized intervention and goal setting. IIG counseling also includes individual “booster” visits every 3 months and monthly group nutrition and support sessions. Dietary data is collected annually via unannounced 24-hour telephone recalls using the Nutrition Data System. Data from the interim analysis (n=293) shows significant dietary change is achieved hi the IIG from baseline to 12 months [% energy from fat (25.9% to 17.2%, median)] with no significant change in NIG participants. This represents a total reduction of fat intake of 39.1% in the IIG. WINS has designed a successful intervention for reducing dietary fat intake in a one on one and group counseling format, thus allowing for definitive evaluation of the effect of dietary fat intake reduction on breast cancer outcome.