Leading Healthy Eating and Activity Promotion Program

NCT06868524 | Recruiting

• 2 other identifiers: IRB-3000109211U54CA280770-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Survivor; Cancer; Oncology

Keywords

cancer survivor; cancer; oncology; exercise; nutrition; diet; healthy lifestyle; behavior change

Outcome Measures

Primary Outcomes (4)

• Number of participants that meet the dietary guidelines for healthy diet

  Measuring the number of participants that meet the dietary guideline's recommendations for fruit and vegetable intake and added sugar.

  Baseline, 12-weeks

• Number of participants that meet the recommended minutes of physical activity per week

  Measuring physical activity from one-week of wearing an accelerometer

  Baseline, 12-weeks

• 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

• Change in 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

Study Arms (1)

Program participants

EXPERIMENTAL

Agree to evaluate a community-based, publicly available program combining a website with optional in person group sessions.

Behavioral: LEAP Program

Interventions

LEAP Program BEHAVIORAL

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.

Program participants

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Laura Rogers, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney McGlawn

CONTACT

205-934-8821; sburdette@uabmc.edu

Marie-Therese Cooper

CONTACT

205-934-6897; marietheresejcooper@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After data management is finalized (and data locked) and the main outcomes manuscript has been submitted.
• Access Criteria: A data use agreement between the institution housing the data (UAB) and the institution of the requesting researcher will be required.

Locations

US (1)