Choose to Lose for Women-Weight Loss to Reduce Breast Cancer Risk Factors

Early Phase 1CompletedNCT01096901

California Polytechnic State University-San Luis Obispo19 enrolled

Overview

This study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention.

In sum, excess body weight and inactivity have emerged as strong avoidable causes of postmenopausal breast cancer, with the greatest potential for primary prevention occurring during the premenopausal years. However, surprisingly, no study to date has examined the effects of a standard behavioral weight loss intervention on breast cancer risk markers in premenopausal women. Understanding the effects of weight loss in premenopausal women is a critical next step in existing research and will inform the development of future breast cancer primary prevention programs. The purpose of this study is to determine the feasibility of recruiting, treating, and retaining 20 overweight/obese women in a 12-week randomized control trial examining feasibility and effects of a behavioral weight loss program on breast cancer risk markers in premenopausal women. Participants will be randomly assigned to either a 12-week comprehensive behavioral weight loss program (n=10) or control condition (n=10). All women will be assessed at baseline and after 3 months of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Obesity Overweight

Interventions

Behavioral Weight lossBEHAVIORAL

Intervention groups will meet weekly for 12 weeks. Weekly meetings will focus on weight loss in women age 30-45 through behavioral weight loss topics. These topics are designed with the Look AHEAD protocols.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Premenopausal women * Age 30-45 * Current BMI of \>25 * English or Spanish speaking * 5th grade reading level * Menstrual regularity, defined as menstrual cycle length of 27-31 and \< 1 missed period within the past 12 months. Exclusion Criteria: * Current use or recent (\< 6 months) use of oral contraceptives, hormones, or other hormone-influencing medications * Pregnant, lactating or planning pregnancy in the next 12 weeks * Unwilling and able to location for intervention visits. * Serious medical condition requiring the supervision of a physician for exercise and diet * History of eating disorder * History of or current use of drugs * Current treatment for serious psychological disorder * Donation of blood within past 6 weeks.

Locations (1)

California Polytechnic State University

San Luis Obispo, California, United States

Outcomes

Primary Outcomes

Weight loss for one group

One group in this randomized study will be focused on weight loss during a 3 month period. The goal is to acheive a 6% weight loss during this time. Specific blood draws will be conducted pre and post weight loss to measure any hormonal changes due to this weight loss.

Time frame: 3 months

Secondary Outcomes

Increased physical activity

The secondary objective in this study is to increase participant activity level to help reduce the risks of certain cancers. As well as increase the overall health of these participants.

Time frame: 3 months

Data from ClinicalTrials.gov

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