Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05839210
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LIFE-L Mediterranean Diet — BEHAVIORAL
    Mediterranean Diet will include goals of: 4+ vegetable servings (2-4 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week. Limit or avoid highly processed foods, sugar-sweetened beverages and foods, processed meats, red meat, and alcohol.
  • LIFE-L Home-Based Exercise Program — BEHAVIORAL
    The Home-Based Exercise Program will include goals of: 150+ minutes moderate or 75+ minutes vigorous exercise per week, completed in sessions of at least 10-minute duration, including daily aerobic exercise plus two resistance-based exercise sessions per week.
  • Supportive Materials — BEHAVIORAL
    Participants will receive an informational study notebook, an exercise reference poster and videos, a Fitbit, and three stretch bands of different intensities. Participants will also receive supportive and informational text messages or emails three (3) times per week during the study; participants can opt-out of these messages. Participants will be requested to utilize the Fitbit app to track exercise sessions, as well as the MyFitnessPal app to track their diet. Support to set up apps will be provided by research staff. For participants who choose not to use the app, a laminated diet and exercise tracking sheet with dry erase marker will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to research staff each week.

Study Details

The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.

Key Dates

Start date
Apr 26, 2023
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: LIFE-L Group
    Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.
  • Other: Control Group
    Participants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention.

Primary Outcome Measure

Percentage of Survivors who participate [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Tracy E Crane, PhD, RDN
[email protected]
305-243-8255
Tracy E Crane, PhD, RDN (PRINCIPAL_INVESTIGATOR)
Craig Moskowitz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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