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Brief Title: 4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity
Official Title: A Proof-of-Concept Study Evaluating a 4:3 Intermittent Fasting Weight Loss Intervention in Adults With Breast Cancer and Overweight or Obesity
Study ID: NCT06399276
Brief Summary: This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anschutz Health and Wellness, Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Name: Victoria Catenacci, MD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR