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ACTIVE NOT RECRUITING
NCT06712797
NA

Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

The purpose of this Study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (PDAC) risk.

Official title: Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-02-19

Completion Date

2027-11

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

BEHAVIORAL

Physical Activity (PA)

Participants will receive a Fitbit (Inspire 3, Google LLC, Mountain View, CA, USA) to encourage and self-monitor Physical Activity (PA) using "active minutes," which approximate moderate-to-vigorous PA. Fitbits will be synced to a HIPAA-compliant platform created by Moffitt's Biostatistics and Bioinformatics Shared Resource (BBSR). Study personnel will view active minutes to provide individualized feedback and encourage progression. Weekly feedback will encourage participants to increase active minutes by 10% until achieving ≥ 150 minutes to meet cancer prevention recommendations. Participants who reach ≥ 150 active minutes will be encouraged to maintain or exceed recommendations.

BEHAVIORAL

Nutrition (N)

Participants will undergo counseling at baseline (T0) to address nutritional symptoms and provide targets for daily calories and protein following a Mediterranean diet. This diet includes a high intake of vegetables, legumes, fruits, and unsaturated fatty acids, low intake of saturated fatty acids, and a moderately high intake of fish. Total caloric intake will be calculated. A standard breakdown of 40% carbohydrates, 30% fats and 30% protein will be used. Individuals will review this calculation during their office encounters and follow these values using the FitBit, application, which will adjust to their daily energy expenditure. Additional counseling (in-person or via Zoom) will occur at baseline (T0) + 12 weeks to gauge progress toward calorie and protein targets, monitor weight change, and guide dietary changes. Participants will log daily food intake and self-monitor progress toward calorie and protein goals.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States