Clinical trial · Interventional
Choose to Lose for Women-Weight Loss to Reduce Breast Cancer Risk Factors
Weight Loss to Reduce Breast Cancer Risk Factors
NCT01096901CI-TRIAL-00019617CTLcompletedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Weight loss | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Comprehensive behavioral weight loss
- 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.
- interventionNames
- Behavioral: Behavioral Weight loss
- type
- NO_INTERVENTION
- label
- Education and Support Control group
- 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.
Primary outcomes (1)
- measure
- Weight loss for one group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.