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

Early Phase 1

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Behavioral Weight loss

• Registration Number: NCT01096901
• Lead Sponsor: California Polytechnic State University-San Luis Obispo

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Study Start: 2010-11
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive behavioral weight loss	Behavioral Weight loss	The group will be implemented to induce a 6% weight loss over 3 months. The lessons will follow protocols from the Look AHEAD trial and Diabetes Prevention Program. This behavioral program has been shown to promote long-term weight loss and a reduction in diabetes and cardiovascular risk factors, and is based on the social cognitive theory.

Primary Outcome Measures

Name	Time	Method
Weight loss for one group	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Increased physical activity	3 months	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.

Trial Locations

Locations (1)

California Polytechnic State University; 🇺🇸 San Luis Obispo, California, United States