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Recruiting

NCT Number: NCT06868524

Leading Healthy Eating and Activity Promotion Program

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.

Recruiting

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Key information

Conditions

Cancer Survivor Behavior Cancer Motor Activity Neoplasms Oncology

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location status: Recruiting

Location contact

Laura Rogers, MD

PRINCIPAL_INVESTIGATOR

Lisa Zubkoff, PhD

SUB_INVESTIGATOR

Marie-Therese Cooper

CONTACT

[email protected]

205-934-6897

Sydney McGlawn

CONTACT

[email protected]

205-934-8821

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Weekly intake of vegetables, fruit, and sugar sweetened beverages

    Time frame: Baseline, 12 weeks

    Each participant reports the average times per week they eat vegetables, eat fruit, and drink sugar sweetened beverages

  2. Average time spent doing physical activity based on accelerometer

    Time frame: Baseline, 12 weeks

    Measuring physical activity from one-week of wearing an accelerometer

  3. Body mass index (BMI)

    Time frame: Baseline, 12 weeks

    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)

Secondary outcomes

  1. Overall quality of life score

    Time frame: Baseline, 12-weeks

    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

  2. Self-report physical activity

    Time frame: Baseline, 12 weeks

    Participants report time per day or week doing moderate intensity physical activity, doing vigorous intensity physical activity, walking, and sitting.

  3. Evaluation of the LEAP Program

    Time frame: 12 weeks

    Participants complete a survey about the LEAP Program activities they did and feedback on the program

  4. Physical performance

    Time frame: Baseline, 12 weeks

    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

Other outcomes

  1. Participant demographic characteristics

    Time frame: Baseline

    Participants complete a survey asking about demographic characteristics (age, sex, race, residence, education, income, employment, etc.)

  2. Participant medical and lifestyle characteristics

    Time frame: Baseline, 12 weeks

    Participants complete a survey about their medical (cancer history, comorbidities), and lifestyle (alcohol, smoking) characteristics.

  3. Food access

    Time frame: Baseline, 12 weeks

    Participants complete a survey asking about the availability of low-fat foods, vegetables, and fruits in their neighborhood

  4. Neighborhood walkability

    Time frame: Baseline, 12 weeks

    Participants complete a survey asking about how easy it is to walk to places in their neighborhood.

  5. Prior participation in the LEAP Program

    Time frame: Baseline

    Participants complete questions about any prior participation in LEAP Program activities or use of the website

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Therese Cooper

CONTACT

[email protected]

205-934-6897

Sydney McGlawn

CONTACT

[email protected]

205-934-8821

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: LEAP

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 11, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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