A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors

NCT ID: NCT02681965

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-04-01

Brief Summary

Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).

Detailed Description

The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.

The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.

Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.

Conditions

Breast Cancer Survivorship; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LEAN

Participants randomized to the weight loss program will initially receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity. Written instructions in the LEAN book will include recording daily diet and exercise in the logs. At the end of the study, participants will return, via a stamped addressed envelope, the logs to the study office so compliance can be assessed.

Group Type: EXPERIMENTAL

LEAN book/videos

Intervention Type: BEHAVIORAL

The intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity.

Waitlist Control

Participants randomized to the waitlist control study arm will be mailed the six-month questionnaires, which will include reporting of weight. On return of the 6-month questionnaires each woman will be provided with the entire weight loss program packet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LEAN book/videos

The intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Overweight individuals (BMI >= 25.0 kg/m2)
• Breast cancer survivors who have completed chemotherapy and/or radiation therapy
• Stage 0-III
• The ability to be physically able to exercise (e.g. walk at a moderate pace)
• Agree to random assignment to either group
• Give informed consent to participate in all study activities
• Accessible by telephone
• Able read and communicate in English

Exclusion Criteria

• Pregnant or intending to become pregnant in the next year
• Recent (past 6 months) stroke or myocardial infarction
• Severe uncontrolled mental illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yale School of Medicine Irwin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

MEPH Chronic Diseases, Yale School of Medicine

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1410014716

Identifier Type: -

Identifier Source: org_study_id