A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors — LEAN3  

Obesity Clinical Trial

Official title: A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer Survivorship
• Breast Neoplasms
• Obesity
• Weight Loss

• NCT number: NCT02681965
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Completion date: April 1, 2018