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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01096901
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
Suzanne Phelan, 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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Behavioral Weight loss Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Weight Loss to Reduce Breast Cancer Risk Factors
Study Start Date : November 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Weight loss for one group [ Time Frame: 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 :
  1. Increased physical activity [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096901

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United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93407
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
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Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo
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Responsible Party: Suzanne Phelan, Principal Investigator, California Polytechnic State University-San Luis Obispo Identifier: NCT01096901    
Other Study ID Numbers: CP-CTL
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes