On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Obesity Prevention for Pre-Adolescents

NCT00185978

Cardiovascular Diseases Heart Diseases Obesity

COMPLETED PHASE2

Family Based Interventions: Preschool Children and Parent

NCT00024843

Cardiovascular Diseases Heart Diseases Obesity

COMPLETED

Study of Technology to Accelerate Research

NCT01537510

Obesity

COMPLETED NA

School and Family-Based Obesity Prevention for Children

NCT00005750

Cardiovascular Diseases Heart Diseases Obesity

COMPLETED

Vascular Health and Exercise Performance of Overweight Children

NCT01729273

Patient Compliance

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular; Change Dietary Modification Physical Activity Health Behavior Attitude to Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

On-Line Diet and Exercise Intervention

Group Type EXPERIMENTAL

On-Line Diet and Exercise Intervention

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

On-Line Diet and Exercise Intervention

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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