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

Obesity Clinical Trial

— CTL  

Official title:

Weight Loss to Reduce Breast Cancer Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096901
• Other study ID #: CP-CTL
• Secondary ID: CP-EFI
• Status: Completed
• Phase: Phase 0
• First received: March 30, 2010
• Last updated: October 26, 2015
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2015
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Behavioral Weight loss
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.

Locations

Country	Name	City	State
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (1)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	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.	3 months	No