search
Back to results

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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Behavioral Weight loss
Sponsored by
California Polytechnic State University-San Luis Obispo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

30 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • California Polytechnic State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Comprehensive behavioral weight loss

Education and Support Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 30, 2010
Last Updated
October 26, 2015
Sponsor
California Polytechnic State University-San Luis Obispo
search

1. Study Identification

Unique Protocol Identification Number
NCT01096901
Brief Title
Choose to Lose for Women-Weight Loss to Reduce Breast Cancer Risk Factors
Acronym
CTL
Official Title
Weight Loss to Reduce Breast Cancer Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive behavioral weight loss
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Education and Support Control group
Arm Type
No Intervention
Arm Description
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 Type
Behavioral
Intervention Name(s)
Behavioral Weight loss
Intervention Description
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 Outcome Measure Information:
Title
Weight loss for one group
Description
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
Secondary Outcome Measure Information:
Title
Increased physical activity
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD.
Organizational Affiliation
California Polytechnic State University-San Luis Obispo
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Polytechnic State University
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93407
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs