Leading Healthy Eating and Activity Promotion Program (LEAP)

Leveraging Adaptation and Multilevel Implementation Strategies to Address Unique Health Promotion Challenges Among Cancer Survivors

The goal of the LEAP project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. This will be done by engaging the community in adapting beneficial approaches for promoting healthy diet and regular physical activity into a program for cancer survivors and co-survivors that is appropriate for the persistent poverty context and social determinants of health.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Cancer Survivor; Oncology
• Intervention / Treatment: Behavioral: LEAP Program

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sydney McGlawn; Phone Number: 205-934-8821; Email: sburdette@uabmc.edu
• Study Contact Backup: Name: Marie-Therese Cooper; Phone Number: 205-934-6897; Email: marietheresejcooper@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Sydney McGlawn; Phone Number: 205-934-8821; Email: sburdette@uabmc.edu
      • Principal Investigator: Laura Rogers, MD
      • Sub-Investigator: Lisa Zubkoff, PhD
      • Contact: Marie-Therese Cooper; Phone Number: 205-934-6897; Email: marietheresejcooper@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

cancer survivors or the friend/family member of a cancer survivor

Description

Inclusion Criteria:

• Between the ages of 18 and 89
• English speaking
• Resident of Birmingham area or surrounding community
• History of any type of cancer or the friend or family with of a cancer survivor

Exclusion Criteria:

• Serious difficulty hearing
• History of dementia or organic brain syndrome
• On primary treatment for cancer
• No other other medical, psychological, or social characteristic that would interfere with participation in evaluation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Program participants; Agree to evaluate a community-based, publicly available program combining a website with optional in person group sessions.	Behavioral: LEAP Program; Combines a publicly available website with educational materials related to healthy eating, regular exercise, and a healthy body weight. Interested community members can also join optional in person community-based events that reinforce the educational material on the website.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly intake of vegetables, fruit, and sugar sweetened beverages	Each participant reports the average times per week they eat vegetables, eat fruit, and drink sugar sweetened beverages	Baseline, 12 weeks
Average time spent doing physical activity based on accelerometer	Measuring physical activity from one-week of wearing an accelerometer	Baseline, 12 weeks
Body mass index (BMI)	Trained research staff will measure height using portable stadiometer (baseline only; no shoes) and weight using portable calibrated scale (light clothing without shoes) to calculate BMI (weight in kg/height in meters squared)	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall quality of life score	self reported survey to collect data about physical, mental, and social health on a scale of 1 to 5 with 5 being excellent and 1 being poor	Baseline, 12-weeks
Self-report physical activity	Participants report time per day or week doing moderate intensity physical activity, doing vigorous intensity physical activity, walking, and sitting.	Baseline, 12 weeks
Evaluation of the LEAP Program	Participants complete a survey about the LEAP Program activities they did and feedback on the program	12 weeks
Physical performance	Number of times a participant can stand up from a chair in 30 seconds and the time it takes for a participant to stand up from a chair, walk 10 feet, and return to sit in the chair	Baseline, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant demographic characteristics	Participants complete a survey asking about demographic characteristics (age, sex, race, residence, education, income, employment, etc.)	Baseline
Participant medical and lifestyle characteristics	Participants complete a survey about their medical (cancer history, comorbidities), and lifestyle (alcohol, smoking) characteristics.	Baseline, 12 weeks
Food access	Participants complete a survey asking about the availability of low-fat foods, vegetables, and fruits in their neighborhood	Baseline, 12 weeks
Neighborhood walkability	Participants complete a survey asking about how easy it is to walk to places in their neighborhood.	Baseline, 12 weeks
Prior participation in the LEAP Program	Participants complete questions about any prior participation in LEAP Program activities or use of the website	Baseline

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Laura Rogers, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: exercise; cancer; oncology; nutrition; healthy lifestyle; cancer survivor; diet; behavior change
• Additional Relevant MeSH Terms: Behavior; Neoplasms; Motor Activity
• Other Study ID Numbers: IRB-300010921; 1U54CA280770-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individuals interested in requesting IPD should contact the study PIs.
• IPD Sharing Time Frame: After data management is finalized (and data locked) and the main outcomes manuscript has been submitted.
• IPD Sharing Access Criteria: A data use agreement between the institution housing the data (UAB) and the institution of the requesting researcher will be required.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No