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Spots Global Cancer Trial Database for 4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity

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Trial Identification

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

Conditions

Breast Cancer

Interventions

Weight Loss

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Anschutz Health and Wellness, Aurora, Colorado, United States

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Contact Details

Name: Victoria Catenacci, MD

Affiliation: University of Colorado, Denver

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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