An Early Phase 1 interventional study of Behavioral Weight loss in Obesity and Overweight, sponsored by California Polytechnic State University-San Luis Obispo. Completed at 1 site in United States. Open to female participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-28.
Sponsored by California Polytechnic State University-San Luis Obispo · Early Phase 1, Interventional, and Prevention
This study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 19 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →California Polytechnic State University-San Luis Obispo is the lead sponsor of 29 studies on the registry; 8 are open to participants now.
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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
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.
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.
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.
Time frame: 3 months
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.
Time frame: 3 months
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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California Polytechnic State University-San Luis Obispo