Vascular; ChangeNCT02519946
On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients
A study testing On-Line Diet and Exercise Intervention in people with Vascular; Change and Dietary Modification, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 19 years
- Conditions the study is for
- Vascular; Change, Dietary Modification, Physical Activity
- What is being tested?
- On-Line Diet and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Acute illness
- Latex allergy
- Document transplant rejection < 3 months
- Re-transplantation or multi-organ transplantation
- Malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Children's Health
Palo Alto, California, 94306
About this study
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.
- Conditions
- Vascular; Change, Dietary Modification, Physical Activity, Health Behavior, Attitude to Health
- Being tested
- On-Line Diet and Exercise Intervention
- Keywords
- Heart Transplantation, Tonometry, Exercise Test, Diet, Cardiovascular Physiology, Telemedicine, Pediatrics, Health Behavior, Physical Fitness, Exercise Movement Techniques, Adolescent Behavior, Child Behavior
- Medical subject headings
- Motor Activity, Health Behavior, Adolescent Behavior, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| On-Line Diet and Exercise Intervention | Experimental | Not described Receives: Other: On-Line Diet and Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Pulse Amplitude Testing Index
Test of endothelial function
Measured: Baseline, 16 weeks, and 32 weeks
Secondary outcomes (6)
Arterial Tonometry
Measured: Baseline, 16 weeks, and 32 weeks
Carotid Artery Imaging
Measured: Baseline, 16 weeks, and 32 weeks
Fasting Low-Density Lipoprotein Level
Measured: Baseline, 16 weeks, and 32 weeks
Volume of Oxygen Consumed at Maximal Exertion
Measured: Baseline, 16 weeks, and 32 weeks
Physical and Psychosocial Health Questionnaire Scores
Both parents and patients will be asked to complete this questionnaire
Measured: Baseline, 16 weeks, and 32 weeks
Functional Movement Screening Score
Participants will be asked to perform certain movements. The range of motion will be scored and totaled for evaluation.
Measured: Baseline, 16 weeks, and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular; ChangeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Tierney, Stanford University
- Investigators
- Elif Seda Selamet Tierney, MD, Principal investigator, Stanford Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519946
- Sponsor's protocol ID
- 15GRNT25680030
- Status last verified
- Sep 2019
- First submitted
- 30 Jul 2015
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31973598
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients
- ClinicalTrials.gov ID
- NCT02519946
- Acronym / sponsor ID
- 15GRNT25680030
- Conditions
- Vascular; Change, Dietary Modification, Physical Activity, Health Behavior, Attitude to Health
- Keywords
- Heart Transplantation, Tonometry, Exercise Test, Diet, Cardiovascular Physiology, Telemedicine, Pediatrics, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On-Line Diet and Exercise Intervention | Experimental | Other: On-Line Diet and Exercise Intervention |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Acute illness
- Latex allergy
- Document transplant rejection < 3 months
- Re-transplantation or multi-organ transplantation
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-Line Diet and Exercise InterventionInitial 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. | Other | On-Line Diet and Exercise Intervention |
Primary outcome
Change in Endothelial Pulse Amplitude Testing Index
Time frame: Baseline, 16 weeks, and 32 weeks
Test of endothelial function
6 secondary outcomes
Arterial Tonometry
Time frame: Baseline, 16 weeks, and 32 weeks
Carotid Artery Imaging
Time frame: Baseline, 16 weeks, and 32 weeks
Fasting Low-Density Lipoprotein Level
Time frame: Baseline, 16 weeks, and 32 weeks
Volume of Oxygen Consumed at Maximal Exertion
Time frame: Baseline, 16 weeks, and 32 weeks
Physical and Psychosocial Health Questionnaire Scores
Time frame: Baseline, 16 weeks, and 32 weeks
Functional Movement Screening Score
Time frame: Baseline, 16 weeks, and 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 31973598Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Seda Selamet Tierney, MD principal investigator
Stanford Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-Line Diet and Exercise Intervention in people with Vascular; Change and Dietary Modification, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endothelial Pulse Amplitude Testing Index (time frame: Baseline, 16 weeks, and 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02519946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.