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Weight Loss to Reduce Breast Cancer Risk Factors


Phase 0
30 Years
45 Years
Not Enrolling
Female
Obesity, Overweight

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Trial Information

Weight Loss to Reduce Breast Cancer Risk Factors


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Weight loss for one group

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Suzanne Phelan, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

California Polytechnic State University-San Luis Obispo

Authority:

United States: Institutional Review Board

Study ID:

CP-CTL

NCT ID:

NCT01096901

Start Date:

November 2010

Completion Date:

June 2011

Related Keywords:

  • Obesity
  • Overweight
  • Breast Neoplasms
  • Obesity
  • Weight Loss
  • Overweight

Name

Location

California Polytechnic State UniversitySan Luis Obispo, California  93407