Exploring the Feasibility, Acceptability, and Safety of a 4:3 Intermittent Fasting Weight Loss Program Among Stage I-III Breast Cancer Survivors With Overweight or Obesity: Protocol for a 6-Month Proof-of-Concept Feasibility Trial
Abstract
Background: Mounting evidence underscores the adverse effects of excess body weight during cancer survivorship, yet many breast cancer survivors struggle to maintain a healthy weight (approximately 70% have overweight or obesity [OW/OB]). Daily caloric restriction with increased physical activity is the standard behavioral weight loss approach; however, many fail to achieve clinically meaningful (>5%) weight loss, emphasizing the need for innovative interventions. A recent investigation found that a behavioral weight loss program focusing on 4:3 intermittent fasting (4:3 IMF) produced 60% greater weight loss among healthy adults with OW/OB with no history of cancer than a program focused on daily caloric restriction. Given these promising results and the need for innovative weight loss strategies among breast cancer survivors, studies testing 4:3 IMF among breast cancer survivors are warranted.
Objective: This investigation aimed to evaluate the feasibility, acceptability, and safety of a 4:3 IMF behavioral weight loss program tailored to breast cancer survivors, and to examine exploratory clinical outcomes (eg, body weight, diet adherence, and physical activity) in relation to prespecified thresholds that will inform whether adjustments to the program are needed prior to progression to a larger trial.
Methods: In this proof-of-concept feasibility study, individuals with stage I-III breast cancer who have OW/OB and are post-primary therapy will enroll in a 6-month behavioral…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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