A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Survivorship
- Sponsor
- Yale University
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Body weight (kg)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Body weight (kg)
Time Frame: 6 Months
A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).
Secondary Outcomes
- Body weight (kg)(12 Months)
- Dietary Intake(12 months)
- Quality of Life (QOL)(6 months)
- Physical Activity (Vigorous)(12 months)
- Physical Activity (Moderate)(12 months)