Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors
HBHL
Healthy Bones, Healthy Life: Effect of Habitual Physical Activity on Bone and Metabolic Health in Pediatric Cancer Survivors
1 other identifier
observational
40
1 country
1
Brief Summary
This project will examine habitual physical activity, bone health, and insulin resistance in pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points: baseline and 6 months. At the two study timepoints, all study participants will be asked to wear an accelerometer, receive a DXA scan of the lumbar spine and hip, and have blood drawn for analysis. Study participants will be given a gift card stipend for each study visit attended. Study visits will coincide with regular office visits to Children's Hospital Oncology Clinic and the Children's Hospital Survivorship Clinics whenever possible. The potential mechanism by which physical activity mediates bone changes will be explored by concurrently measuring changes in lean/fat mass and metabolic status. This pilot study will provide data to inform the design of a randomized controlled trial to test the effect of a physical activity intervention on bone health in PCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedAugust 30, 2024
August 1, 2024
3.6 years
July 10, 2020
August 28, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Bone Mineral Density (g/cm2)
z-score of lumbar Spine bone density- DXA scan
6 months
Hip structural analysis
DXA scan
6 months
Physical Activity Level
Physical Activity as measured by accelerometry
6 months
Secondary Outcomes (4)
Lipid panel
6 months
Homeostatic Model Assessment for Insulin Resistance
6 months
Hemoglobin A1c
6 months
Vitamin D
6 months
Study Arms (1)
Pediatric Cancer Survivors
Children and adolescents who have completed treatment of for acute lymphoblastic leukemia (ALL) and lymphoma.
Eligibility Criteria
Pediatric cancer survivors who are in the first year after treatment completion
You may qualify if:
- Children between the ages of 5-18
- Diagnosis of ALL or Lymphoma
- Between 1-13 months post-cancer treatment
You may not qualify if:
- Children younger than 5 years old or 19 or older
- Children without a diagnosis of ALL or lymphoma
- Children receiving ongoing cancer treatment
- Children with Down syndrome (identified as a precancerous condition affecting BMD)
- Children with a prior history of bisphosphonate use or other medication directed at increasing bone density
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura D Bilek, PhD
University of Nebraska
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 15, 2020
Study Start
November 1, 2020
Primary Completion
May 30, 2024
Study Completion
May 30, 2024
Last Updated
August 30, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share