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

NCT06399276 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Victoria Catenacci, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06399276 on ClinicalTrials.gov