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

This study has been completed.
Sponsor:
Information provided by:
California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier:
NCT01096901
First received: March 30, 2010
Last updated: August 2, 2011
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Obesity
Overweight
Behavioral: Behavioral Weight loss
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Weight Loss to Reduce Breast Cancer Risk Factors

Resource links provided by NLM:


Further study details as provided by California Polytechnic State University-San Luis Obispo:

Primary Outcome Measures:
  • Weight loss for one group [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Increased physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096901

Locations
United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93407
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Investigators
Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo
  More Information

No publications provided

Responsible Party: Suzanne Phelan, California Polytechnic State University
ClinicalTrials.gov Identifier: NCT01096901     History of Changes
Other Study ID Numbers: CP-CTL, CP-EFI
Study First Received: March 30, 2010
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Weight Loss
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 22, 2014