NCT06399276

4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity

A Proof-of-Concept Study Evaluating a 4:3 Intermittent Fasting Weight Loss Intervention in Adults With Breast Cancer and Overweight or Obesity

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Weight Loss	Participants are instructed to perform a modified fast (\~500 kcal) on 3 days/week with ad libitum intake the other 4 days/week. Group-based behavioral support sessions will be held by an experienced Registered Dietician. Participants will attend BfitBwell exercise sessions in person and virtually to receive individualized support to progress to 150 min/wk of moderate-intensity physical activity

Timeline

• Start date: 2024-05-28
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2024-05-03
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States