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

NCT06712797 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Miles for Moffitt

    collaborator UNKNOWN

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jennifer Permuth, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2026-09-30
Completion
2027-11-30

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 NCT06712797 on ClinicalTrials.gov