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.|
|ClinicalTrials.gov Identifier: NCT01096901|
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : October 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight||Behavioral: Behavioral Weight loss||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Weight Loss to Reduce Breast Cancer Risk Factors|
|Study Start Date :||November 2010|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01096901
|United States, California|
|California Polytechnic State University|
|San Luis Obispo, California, United States, 93407|
|Principal Investigator:||Suzanne Phelan, PhD.||California Polytechnic State University-San Luis Obispo|