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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
24
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.
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.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGRetention 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%).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: Up to 6 Months
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