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NCT06399276Not yet recruiting

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
University of Colorado, DenverClinicalTrials.govbehavioral
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
Weight Loss
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
University of Colorado, Denver
Location
Aurora,Aurora, United States of America
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Jun 01, 2027
Enrollment
36 participants
Primary outcome

Body Weight,Adherence to 4:3 Intermittent Fasting Dietary Paradigm as Measured by Food Records,Physical Activity

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.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06399276
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06399276 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Colorado, Denver and is currently Not yet recruiting. The study focuses on Breast Cancer. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.