Recruiting

Lifestyle Intervention

Sponsor:

University of Miami

Code:

NCT05839210

Conditions

Non Hodgkin Lymphoma

Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LIFE-L Mediterranean Diet

LIFE-L Home-Based Exercise Program

Supportive Materials

Study Details

Brief summary:

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.

Conditions

Non Hodgkin Lymphoma

Hodgkin Lymphoma

Study ID

NCT05839210

Start date

Apr 26, 2023

Status verified date

Jan, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years of age or older
2. Any sex/gender
3. Able to provide consent
4. Able to read or understand English or Spanish
5. Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:

1. R-CHOP or R-CHOP-like regimen
2. BR
3. BV-AVD or ABVD or checkpoint inhibitor+AVD
6. ECOG Performance Status grade of <2

a. PI approval needed if ECOG = 2
7. Approval from treating oncologist, confirmed via email or in writing
8. Delivery of chemotherapy treatments at one of the following institutions:

1. Sylvester Comprehensive Cancer Center (including satellite/network sites)
2. University of Miami Hospital/UHealth Tower
9. Internet access on a smart phone, tablet, or computer
10. Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.

Exclusion Criteria:

1. Individuals younger than 18 years of age
2. Unable to provide consent
3. Unable to read or understand English or Spanish
4. Any contraindication for diet change or exercising as determined by physician
5. Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
6. Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
7. History of dementia or major psychiatric disease
8. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

LIFE-L Mediterranean Diet

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

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

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.

Primary outcome measure

  • Percentage of Survivors who participate [ Time Frame: Up to 12 months ]
  • Percentage of Participants Completing Intervention Sessions [ Time Frame: Up to 26 weeks (Post-Intervention) ]
  • Change in percentage of participant satisfaction [ Time Frame: 4 weeks (post-intervention), up to 30 weeks ]

Central Contacts and Locations

Central contacts

Tracy E Crane, PhD, RDN

305-243-8255tecrane@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Tracy E Crane, PhD, RDN

305-243-8255tecrane@med.miami.edu

Principal Investigator:

Tracy E Crane, PhD, RDN

More Information

Sponsor

University of Miami

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Mediterranean Diet
  • Exercise Program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-01-30.