NCT02681965

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-02-15
• Last updated: 2018-06-29

Locations

1 site across 1 country: United States