4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity - Trial NCT06399276
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.
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Study Focus
Sponsor & Location
University of Colorado, Denver
Timeline & Enrollment
N/A
Jun 01, 2024
Jun 01, 2027
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
Data Source
ClinicalTrials.gov
NCT06399276
Non-Device Trial