Physical Activity And Nutrition To Halt Elevated Risk In The Pancreas Interception Center

Study Overview

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

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.

N/A

Pancreatic Ductal Adenocarcinoma
Intraductal Papillary Mucinous Neoplasm

BEHAVIORAL: Physical Activity (PA)
BEHAVIORAL: Nutrition (N)

MCC-23462

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-11-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-05
First Submitted that Met QC Criteria 2024-11-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-06
First Posted (ACTUAL) 2024-12-02	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Physical Activity (PA) and Nutrition (N) Physical Activity: Participants will perform 150 minutes/week of moderate to vigorous Physical Activity per week. Participants will self-monitor physical activity using "active minutes" that approximate moderate to vigorous physical activity via a Fitbit	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 platfor 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Physical Activity (PA) and Nutrition (N)

Physical Activity: Participants will perform 150 minutes/week of moderate to vigorous Physical Activity per week. Participants will self-monitor physical activity using "active minutes" that approximate moderate to vigorous physical activity via a Fitbit

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 platfor

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

Primary Outcome Measures	Measure Description	Time Frame
Retention Feasibility	Retention feasibility will be measured based on the percentage of enrolled participants who complete study assessments during the 6-month duration of enrollment (baseline T0 through follow-up T1) Target: ≥70%).	Up to 6 Months
Physical Activity (PA) Adherence Feasibility	Adherence to Physical Activity (PA) will be based on achievement of activity minute goals (≥ 150 minutes). Target: 70% of participants achieve activity minute goals in ≥75% of full weeks between baseline through follow-up (T0-T1).	Up to 6 Months
Nutrition (N) Adherence Feasibility	Adherence to Nutrition (N) will be based on completion of counseling appointments (target: 70% of participants complete both appointments) and diet logging. Target: 70% of participants log diet on ≥ 50% of days between baseline through follow-up (T0-T1)	Up to 6 Months
Acceptability of Lifestyle Modifications	Acceptability will be assessed at T1 with the Participant Evaluation of Feasibility and Acceptability questionnaire, adapted to fit intervention conditions used in this study. This questionnaire includes Likert Scale and open-ended questions assessing difficulty and appropriateness of the Physical Acitivity (PA) and Nutrition (N) intervention components, perceived benefits, interactions with study personnel, study materials, and baseline/follow-up testing. Acceptability will be assessed on an item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability.	Up to 6 Months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jennifer Permuth, PhD

Phone Number: 813-745-5744

Email: Jenny.Permuth@moffitt.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age 18 years or older
Endoscopically, radiologically, or biopsy-proven pancreatic intraductal papillary mucinous neoplasm (IPMN) over 15 mm in size
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Ability to sign informed consent
Ability to read and speak English or Spanish
Body Mass Index (BMI) greater than or equal to 25 kg/m2
Visceral obesity based on MRI quantification of visceral and subcutaneous fat; ratio of visceral to subcutaneous fat area greater than 0.4 and/or elevated cytokine, incretin or adipokine biomarkers

No diagnosis of an IPMN
IPMN with high grade dysplasia, cancer or other high-risk features
Screen failure for exercise safety
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
Recent fracture or acute musculoskeletal injury
Numeric pain rating scale of 7 or more out of 10
Myopathic or rheumatologic disease that impacts physical function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Miles for Moffitt

Investigators

PRINCIPAL_INVESTIGATOR: Shaffer Mok, MD, Moffitt Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record