ObesityNCT01580319
Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
A study testing physical exercise in people with Obesity and Hypercholesterolemia, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
This research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypercholesterolemia, High Blood Pressure
- What is being tested?
- physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2009to Dec 2011
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 17 years
- obesity
- high cholesterol
Who cannot join
- congenital heart diseases
- less than 6 or more than 17 years old
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620-001
About this study
Official title: Outpatient Strategy of Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
This research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol.
Read the detailed description
Control Group: receive information about health lifestyle Interventional Group: receive a structured plan with exercises to do 3 times per week within 50 minutes.
It is a randomized clinical trial and population are children and adolescents.
- Being tested
- physical exercise
- Keywords
- obesity, cholesterol, cholesterol, LDL, cholesterol, HDL, blood glucose, Triglyceride, C-Reactive Protein - hs, blood pressure, physical activity, Sedentary Lifestyle
- Medical subject headings
- Obesity, Hypercholesterolemia, Hypertension, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseOther
Also called physical activity, exercise
150 minutes per week
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants do not receive a physical exercise plan. Participants receive a simple orientations about lifestyle activities. |
| Exercise | Experimental | Participants receive a physical exercise plan to play at home Receives: Other: physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction on risk factors for a cardiovascular diseases (reduction on BMI, cholesterol, LDL, glucose, high-sensitivity C-reactive protein, blood pressure and/or increase on HDL)
These measurement (taken at end of study) are assessed for a external research (blind for randomization) to judge the individual outcome.
Measured: These measurement were taken at end of followup (27th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2011
Why it stopped: Difficulty in selecting the sample and follow-up lost.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Principal investigator, Claudia Ciceri Cesa, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Claudia C Cesa, MS, Principal investigator, Instituto de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580319
- Sponsor's protocol ID
- 2994/01
- Status last verified
- May 2012
- First submitted
- 30 Jun 2011
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Strategy of Primary Prevention of Cardiovascular Diseases in Childhood and Adolescence: the Role of Physical Activity
- ClinicalTrials.gov ID
- NCT01580319
- Acronym / sponsor ID
- 2994/01
- Keywords
- obesity, cholesterol, cholesterol, LDL, cholesterol, HDL, blood glucose, Triglyceride, C-Reactive Protein - hs, blood pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in selecting the sample and follow-up lost.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Apr 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.
This research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol.
Detailed description
Control Group: receive information about health lifestyle Interventional Group: receive a structured plan with exercises to do 3 times per week within 50 minutes.
It is a randomized clinical trial and population are children and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants do not receive a physical exercise plan. Participants receive a simple orientations about lifestyle activities. |
| Exercise | Experimental | Other: physical exerciseParticipants receive a physical exercise plan to play at home |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 to 17 years
- obesity
- high cholesterol
Key exclusion criteria (2 listed)
- congenital heart diseases
- less than 6 or more than 17 years old
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 |
|---|---|---|
| physical exerciseAlso: physical activity, exercise150 minutes per week | Other | Exercise |
Primary outcome
Reduction on risk factors for a cardiovascular diseases (reduction on BMI, cholesterol, LDL, glucose, high-sensitivity C-reactive protein, blood pressure and/or increase on HDL)
Time frame: These measurement were taken at end of followup (27th week)
These measurement (taken at end of study) are assessed for a external research (blind for randomization) to judge the individual outcome.
Results and safety
The study was stopped early (reason given: Difficulty in selecting the sample and follow-up lost.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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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.
Claudia C Cesa, MS principal investigator
Instituto de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Obesity and Hypercholesterolemia, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 May 2012. 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 Brazil. 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 was stopped early (reason given: Difficulty in selecting the sample and follow-up lost.). Results are not available in the source record.
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?
Reduction on risk factors for a cardiovascular diseases (reduction on BMI, cholesterol, LDL, glucose, high-sensitivity C-reactive protein, blood pressure and/or increase on HDL) (time frame: These measurement were taken at end of followup (27th 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 9 May 2012.