NCT02519946

Brief Summary

Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their long-term outcomes and survival. Currently, no effective cardiovascular preventative care is provided for this pediatric population, in part, due to the fact that clinic-based programs are not easily accessible to children and their families. However, tele-health has been show to improve medical outcomes by making care more accessible to these patients. This study aims to meet the urgent need for an effective and sustainable delivery of preventative care to pediatric heart transplant patients using a diet and exercise intervention program delivered live over the internet direct to these patients' homes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

3.4 years

First QC Date

July 30, 2015

Last Update Submit

September 17, 2019

Conditions

Vascular; ChangeDietary ModificationPhysical ActivityHealth BehaviorAttitude to Health

Keywords

Heart TransplantationTonometryExercise TestDietCardiovascular PhysiologyTelemedicinePediatricsHealth BehaviorPhysical FitnessExercise Movement TechniquesAdolescent BehaviorChild Behavior

Outcome Measures

Primary Outcomes (1)

  • Change in Endothelial Pulse Amplitude Testing Index

    Test of endothelial function

    Baseline, 16 weeks, and 32 weeks

Secondary Outcomes (6)

  • Arterial Tonometry

    Baseline, 16 weeks, and 32 weeks

  • Carotid Artery Imaging

    Baseline, 16 weeks, and 32 weeks

  • Fasting Low-Density Lipoprotein Level

    Baseline, 16 weeks, and 32 weeks

  • Volume of Oxygen Consumed at Maximal Exertion

    Baseline, 16 weeks, and 32 weeks

  • Physical and Psychosocial Health Questionnaire Scores

    Baseline, 16 weeks, and 32 weeks

  • +1 more secondary outcomes

Study Arms (1)

On-Line Diet and Exercise Intervention

EXPERIMENTAL
Other: On-Line Diet and Exercise Intervention

Interventions

On-Line Diet and Exercise InterventionOTHER

Initial 16 weeks of on-line, live exercise instruction 3x/week and on-line, diet sessions followed by 16 weeks of weekly exercise and diet sessions.

On-Line Diet and Exercise Intervention

Eligibility Criteria

Age9 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Heart transplant \>11 months before baseline visit
  • Able to fast overnight
  • Cardiac clearance to exercise by the primary cardiologist
  • Presence of an adult at home during the exercise training sessions for patients \< 14 years of age

You may not qualify if:

  • Acute illness
  • Latex allergy
  • Document transplant rejection \< 3 months
  • Re-transplantation or multi-organ transplantation
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Children's Health

Palo Alto, California, 94306, United States

Location

Related Publications (1)

  • Chen AC, Ramirez FD, Rosenthal DN, Couch SC, Berry S, Stauffer KJ, Brabender J, McDonald N, Lee D, Barkoff L, Nourse SE, Kazmucha J, Wang CJ, Olson I, Selamet Tierney ES. Healthy Hearts via Live Videoconferencing: An Exercise and Diet Intervention in Pediatric Heart Transplant Recipients. J Am Heart Assoc. 2020 Feb 4;9(3):e013816. doi: 10.1161/JAHA.119.013816. Epub 2020 Jan 24.

    PMID: 31973598DERIVED

MeSH Terms

Conditions

Motor ActivityHealth BehaviorAdolescent BehaviorChild Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elif Seda Selamet Tierney, MD

    Stanford Children's Hospital

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 11, 2015

Study Start

August 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

US(1)