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Behavioral Intervention

In-Person or Telephone-Based Counseling for Breast Cancer (LEAN 2 Trial)

N/A
Waitlist Available
Led By Melinda L Irwin, PhD, MPH
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

LEAN 2 Trial Summary

This trial will compare a weight loss program to usual care to see if it affects weight, body fat, hormone levels, and breast tissue markers associated with prognosis.

Eligible Conditions
  • Breast Cancer
  • Weight Loss

LEAN 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Mass Index (BMI)
Change in body weight in kilograms (kg)
Change in breast tissue markers
+1 more
Secondary outcome measures
Change in C-reactive protein
Change in Leptin
Change in fasting insulin
+3 more
Other outcome measures
Change in Dietary Intake
Change in Physical Activity

LEAN 2 Trial Design

2Treatment groups
Active Control
Group I: In-Person or Telephone-Based CounselingActive Control1 Intervention
The exact same information, content, schedule, and 30 minute sessions will be provided to telephone-based participants as offered to participants who receive in-person counseling. Participants will be taught diet, exercise and behavior change strategies via the telephone (weekly calls for month 1, every other week for months 2-3, and monthly for months 4-6). All lessons and diet and physical activity logs will be mailed to them at the beginning of the program. Participants will record their daily diet and exercise in the logs.
Group II: Usual Care/Wait ListActive Control1 Intervention
At 6-months the participants in the Wait List group may choose to participate in the 11 sessions either in-person or via telephone or a combination of the two modes of delivery. They will also be offered the opportunity to return to Yale at 12-months (immediately after the end of the 6-month counseling sessions) to have weight and DEXA measured.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,390 Total Patients Enrolled
26 Trials studying Breast Cancer
3,184 Patients Enrolled for Breast Cancer
Melinda L Irwin, PhD, MPHPrincipal InvestigatorYale University
2 Previous Clinical Trials
300 Total Patients Enrolled
2 Trials studying Breast Cancer
300 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Breast Cancer Research and TreatmentJournal
Examining the Effect of Obesity-associated Gene Variants on Breast Cancer Survivors in a Randomized Weight Loss Intervention
Nguyen, ThaiHien, Melinda L. Irwin, Andrew T. Dewan, Brenda Cartmel, Maura Harrigan, Leah M. Ferrucci, Tara Sanft, Fangyong Li, Lingeng Lu, and Yasmmyn D. Salinas. 2021. “Examining the Effect of Obesity-associated Gene Variants on Breast Cancer Survivors in a Randomized Weight Loss Intervention”. Breast Cancer Research and Treatment. Springer Science and Business Media LLC. doi:10.1007/s10549-021-06151-5.
clinicaltrials.govStudy
Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)
2013. "Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02110641.
~4 spots leftby Apr 2025
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