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

Weight Loss to Reduce Breast Cancer Risk Factors

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

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Behavioral Weight loss

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93407
      • California Polytechnic State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comprehensive 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.	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.
No Intervention: Education and Support Control group; Participants in this group will receive support and education about healthy eating and activity with lessons based on the Look AHEAD support and education control condition. Participants will attend monthly closed group meetings and meetings will be designed to promote retention but not weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (Estimate): March 31, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: CP-CTL; CP-EFI