Patient ComplianceVHEPOCNCT01729273
Vascular Health and Exercise Performance of Overweight Children
A study testing Diet and Exercise Intervention in people with Patient Compliance, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to assess exercise performance in 20 healthy children 10-19 years of age with a body mass index greater than 85th percentile and to evaluate the effect of dietary and exercise intervention over 12 weeks. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Compliance
- What is being tested?
- Diet and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2014
- 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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 10-19 years old
- Overweight (BMI > 85 percentile)
- Interested in a 12 week ¬home exercise \& nutrition program
- Have computer \& internet access
- Can come to Lucile Packard Children's Hospital at Stanford for a 3-hour test at the start \& end of the study (so only twice!)
- Are able to come to testing after fasting overnight
- Do not smoke
- Do not take any medications
Who cannot join
- non-overweight adolescents
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94306
About this study
Official title: Vascular Health and Exercise Performance of Overweight Children in 12 Weeks Using Skype
The purpose of this study is to assess exercise performance in 20 healthy children 10-19 years of age with a body mass index greater than 85th percentile and to evaluate the effect of dietary and exercise intervention over 12 weeks.
Read the detailed description
Our hypothesis is that the vascular health in these children will improve at the end of intervention. The results of this study will help us in our long-term objective of improving vascular health of children with congenital/acquired heart disease, a group particularly at risk for premature atherosclerosis.
- Conditions
- Patient Compliance
- Being tested
- Diet and Exercise Intervention
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and Exercise InterventionOther
Remote Dietary and Exercise Intervention Program
| Study group | Role | What they receive |
|---|---|---|
| Diet and Exercise Intervention | Experimental | Tests will include EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP).
The Home Exercise Program will be 3 days a week for 12 weeks and participants will connect with the trainer to perform 45-60 minutes of a combination of strength training and aerobic activity via Skype. The Dietary Approaches to Stop Hypertension(DASH) eating pattern will be prescribed to all participants in the treatment group and specific strategies to achieve goals will be discussed weekly by the participant over the phone. Receives: Other: Diet and Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Health
Tests will include: EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP). The participant will be asked to come in after an overnight fast. They will receive a snack bag before the exercise test.
Measured: Beginning of 12th week and end of 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seda Tierney, MD, Principal investigator, Lucile Packard Children's Hospital - Pediatric CardiologyChau N Vu, BS, Study director, Lucile Packard Children's Hospital - Pediatric CardiologyKatie Jo Buccola, Study chair, Lucile Packard Children's Hospital - Pediatric CardiologyJeffrey Kazmucha, Study chair, Lucile Packard Children's Hospital - Pediatric CardiologyLaurie Steinberg, Study chair, Stanford Prevention Research CenterOlga Ogareva, Study chair, Lucile Packard Children's Hospital - Pediatric CardiologyInger Olson, MD, Study chair, Lucile Packard Children's Hospital - Pediatric CardiologyChinyelu Nwobu, MD, Study chair, Lucile Packard Children's Hospital - Pediatric Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729273
- Sponsor's protocol ID
- CHRI-23724
- Acronym
- VHEPOC
- Status last verified
- Oct 2014
- First submitted
- 13 Nov 2012
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Health and Exercise Performance of Overweight Children in 12 Weeks Using Skype
- ClinicalTrials.gov ID
- NCT01729273
- Acronym / sponsor ID
- VHEPOC / CHRI-23724
- Conditions
- Patient Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Nov 2012 (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.
The purpose of this study is to assess exercise performance in 20 healthy children 10-19 years of age with a body mass index greater than 85th percentile and to evaluate the effect of dietary and exercise intervention over 12 weeks.
Detailed description
Our hypothesis is that the vascular health in these children will improve at the end of intervention. The results of this study will help us in our long-term objective of improving vascular health of children with congenital/acquired heart disease, a group particularly at risk for premature atherosclerosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet and Exercise Intervention | Experimental | Other: Diet and Exercise InterventionTests will include EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP). The Home Exercise Program will be 3 days a week for 12 weeks and participants will connect with the trainer to perform 45-60 minutes of a combination of strength training and aerobic activity via Skype. The Dietary Approaches to Stop Hypertension(DASH) eating pattern will be prescribed to all participants in the treatment group and specific strategies to achieve goals will be discussed weekly by the participant over the phone. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 10-19 years old
- Overweight (BMI > 85 percentile)
- Interested in a 12 week ¬home exercise \& nutrition program
- Have computer \& internet access
- Can come to Lucile Packard Children's Hospital at Stanford for a 3-hour test at the start \& end of the study (so only twice!)
Key exclusion criteria (1 listed)
- non-overweight adolescents
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 |
|---|---|---|
| Diet and Exercise InterventionRemote Dietary and Exercise Intervention Program | Other | Diet and Exercise Intervention |
Primary outcome
Vascular Health
Time frame: Beginning of 12th week and end of 12th week
Tests will include: EndoPAT analysis to assess endothelial function, applanation tonometry to assess arterial stiffness, carotid artery imaging to assess the wall thickness of the carotid arteries, exercise testing to assess the physical exercise capacity of these children and blood work to evaluate the lipid profile and inflammation status (CRP). The participant will be asked to come in after an overnight fast. They will receive a snack bag before the exercise test.
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 6 Oct 2014.
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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.
Seda Tierney, MD principal investigator
Lucile Packard Children's Hospital - Pediatric Cardiology
Chau N Vu, BS study director
Lucile Packard Children's Hospital - Pediatric Cardiology
Katie Jo Buccola study chair
Lucile Packard Children's Hospital - Pediatric Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Exercise Intervention in people with Patient Compliance, 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 8 inclusion and 1 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 6 Oct 2014. 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?
Vascular Health (time frame: Beginning of 12th week and end of 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2014.