Clinical trial · Interventional
Lifestyle, Exercise and Nutrition Study 1
Lifestyle, Exercise and Nutrition (LEAN) Study 1
NCT02109068CI-TRIAL-00014220LEANcompletedPhase 3ClinicalTrials.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)
The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, and serum hormones in breast cancer survivors.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Weight Loss Counseling- In-Person | Behavioral | — | UNRESOLVED |
| Weight Loss Counseling- Phone | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- In-Person Counseling
- description
- Participants randomized to in-person counseling will meet via in-person or via telephone (but at least 3 of the 11 sessions must be in person) weekly for month 1, then every other week for months 2, and 3, and then monthly for months 4-6 at Yale University. The meetings will last 30 minutes. Participants will turn in their diet and exercise logs and also be weighed. A lesson will then be discussed (see above for content).
- interventionNames
- Behavioral: Weight Loss Counseling- In-Person
- type
- ACTIVE_COMPARATOR
- label
- Telephone-based Counseling
- description
- 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. Every four weeks, participants will return, via stamped, addressed envelopes, the logs to the study office.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer * BMI \>25 kg/m2 * Completed surgery, chemotherapy and radiation at least 2 months ago * Physically able to exercise * Agrees to be randomly assigned to either weight loss or control * Gives informed consent to participate in all study activities * Able to come for baseline and 6-month clinic visits * Mentally competent Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.