Trial Information

Adolescent Diet, Hormones and Breast Cancer Susceptibility

OBJECTIVES:

Primary

- Determine the long-term effect of the Dietary Intervention Study in Children (DISC) to
lower total fat and saturated fat intake during adolescence on serum progesterone
levels in young women previously enrolled in the DISC study.

Secondary

- Determine the long-term effect of the DISC intervention on serum estradiol levels in
these women.

- Determine the long-term effect of the DISC intervention on bone mineral density in
these women.

- Determine the long-term effect of the DISC intervention on breast density in these
women.

- Determine the long-term effect of the DISC intervention on the prevalence of metabolic
syndrome in these women.

OUTLINE: This is a multicenter study.

Patients undergo fasting blood collection on day 1 for assessment of serum hormones
(progesterone, estradiol), lipids, lipoproteins, and fasting glucose. Patients also undergo
blood pressure, height, weight, and waist circumference measurements. Patient then receive a
snack and complete the Modifiable Activity questionnaire, Center for Epidemiological Studies
Depression Scale short form, Spielberger State-Trait Anxiety Inventory, and Dietary
Intervention Study in Children Medical History questionnaire (including demographics,
medical history, menstrual history, medications, reproductive history, dietary supplements,
alcohol and tobacco use, and family history of cancer). Patients also undergo dual-energy
x-ray absorptiometry (DEXA) and MRI to measure bone and breast density. Patients complete an
in-person 24-hour dietary recall using the Nutrition Data System for Research on day 1 and
via telephone once in weeks 2 and 3.

Day 1 is scheduled during the patient's luteal phase of menstrual cycle. After completion of
study, patients contact the clinic to report start of next menses.

PROJECTED ACCRUAL: A total of 301 patients will be accrued for this study.