Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)

Yale University

Status: Completed

Conditions: Weight Loss; Breast Cancer

Treatments: Behavioral: Weight Loss Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02110641

1012007780_1

Details and patient eligibility

About

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, serum hormones, and breast tissue markers associated with prognosis in breast cancer survivors.

Full description

We will conduct a two-armed study comparing a combination of an in-person and telephone weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women will be randomized into one of the study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

• Patients with double mastectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

In-Person or Telephone-Based Counseling

Active Comparator group

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.

Treatment:

Behavioral: Weight Loss Counseling

Usual Care/Wait List

No Intervention group

Description:

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.