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

NCT01096901 | Completed Early Phase 1

• 2 other identifiers: CP-CTLCP-EFI
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Increased physical activity

  3 months

Study Arms (2)

Comprehensive behavioral weight loss

ACTIVE COMPARATOR

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

Education and Support Control group

NO INTERVENTION

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.

Interventions

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.

Comprehensive behavioral weight loss

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women
• Age 30-45
• Current BMI of \>25
• English or Spanish speaking
• th grade reading level
• Menstrual regularity, defined as menstrual cycle length of 27-31 and \< 1 missed period within the past 12 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Phelan, PhD.

  California Polytechnic State University-San Luis Obispo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

US (1)