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Completed

NCT Number: NCT01096901

Choose to Lose for Women-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.

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Key information

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

California Polytechnic State University

San Luis Obispo, California, 93407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral weight loss

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Registry information

Official study title

Weight Loss to Reduce Breast Cancer Risk Factors

Acronym: CTL

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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