Child ObesityNCT03080376
Home Exercise Intervention in Childhood Obesity
A study testing Web-based intervention with support, Web-based intervention without support and Traditional intervention in people with Child Obesity, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Aim: To evaluate the impact of a physical exercise Web-based program with or without support on body composition, physical fitness and blood pressure values. Design: Randomized Controlled Trial. Population: Obese children and adolescents. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Child Obesity
- What is being tested?
- Web-based intervention with support, Web-based intervention without support and Traditional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to 31 May 2017
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Overweight or obese children and adolescents
Who cannot join
- Secondary obesity syndromes
- Severe obesity (z score > 2.5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Exercise Intervention in Childhood Obesity: Randomized Clinical Trial Comparing Print-based Versus Web-based Platform
Aim: To evaluate the impact of a physical exercise Web-based program with or without support on body composition, physical fitness and blood pressure values.
Design: Randomized Controlled Trial. Population: Obese children and adolescents.
Read the detailed description
In recent years there has been a decline in levels of physical activity (PA) in both children and adults. The promotion of PA is also a key element in the treatment of obesity, along with changing eating habits, but usually has very low levels of adherence. Active video games may be an alternative for the promotion of PA in the treatment of obesity.
The objective of this project is to evaluate the impact of a physical exercise Web-based program with or without support on Body Composition, Physical Fitness and Blood Pressure values.
- Conditions
- Child Obesity
- Being tested
- Web-based intervention with support, Web-based intervention without support, Traditional intervention
- Keywords
- Exercise, Web-based intervention
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based intervention with supportOther
Web-based combined aerobics and muscular strength exercises.
Web-based intervention without supportOther
Web-based combined aerobics and muscular strength exercises.
Traditional interventionOther
3 months of Printed-based combined aerobics and muscular strength exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Web-based intervention without support | Experimental | 3 months Web-based intervention without support Receives: Other: Web-based intervention without support |
| Web-based intervention with support | Experimental | 3 months Web-based intervention with support (e-mails) Receives: Other: Web-based intervention with support |
| Traditional intervention | Active comparator | 3 months of Printed-based intervention Receives: Other: Traditional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of body fat
Percentage of body fat
Measured: Change from Baseline Percentage of body fat at 3 months
Secondary outcomes (3)
Hand strength
Hand strength
Measured: Change from Baseline Hand strength at 3 months
Oxygen consumption peak
Oxygen consumption peak
Measured: Change from Baseline Oxygen consumption peak at 3 months
Blood pressure
Blood pressure
Measured: Change from Baseline Blood Pressure at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 Mar 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JF Lisón, Dr, Study director, University CEU Cardenal Herrera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080376
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-5
- Status last verified
- Sep 2017
- First submitted
- 5 Mar 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Exercise Intervention in Childhood Obesity: Randomized Clinical Trial Comparing Print-based Versus Web-based Platform
- ClinicalTrials.gov ID
- NCT03080376
- Acronym / sponsor ID
- UNIVERSITY CARDENAL HERRERA-5
- Conditions
- Child Obesity
- Keywords
- Exercise, Web-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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.
Aim: To evaluate the impact of a physical exercise Web-based program with or without support on body composition, physical fitness and blood pressure values.
Design: Randomized Controlled Trial. Population: Obese children and adolescents.
Detailed description
In recent years there has been a decline in levels of physical activity (PA) in both children and adults. The promotion of PA is also a key element in the treatment of obesity, along with changing eating habits, but usually has very low levels of adherence. Active video games may be an alternative for the promotion of PA in the treatment of obesity.
The objective of this project is to evaluate the impact of a physical exercise Web-based program with or without support on Body Composition, Physical Fitness and Blood Pressure values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Web-based intervention without support | Experimental | Other: Web-based intervention without support3 months Web-based intervention without support |
| Web-based intervention with support | Experimental | Other: Web-based intervention with support3 months Web-based intervention with support (e-mails) |
| Traditional intervention | Active comparator | Other: Traditional intervention3 months of Printed-based intervention |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Overweight or obese children and adolescents
Key exclusion criteria (2 listed)
- Secondary obesity syndromes
- Severe obesity (z score > 2.5)
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 |
|---|---|---|
| Web-based intervention with supportWeb-based combined aerobics and muscular strength exercises. | Other | Web-based intervention with support |
| Web-based intervention without supportWeb-based combined aerobics and muscular strength exercises. | Other | Web-based intervention without support |
| Traditional intervention3 months of Printed-based combined aerobics and muscular strength exercise intervention. | Other | Traditional intervention |
Primary outcome
Percentage of body fat
Time frame: Change from Baseline Percentage of body fat at 3 months
Percentage of body fat
3 secondary outcomes
Hand strength
Time frame: Change from Baseline Hand strength at 3 months
Oxygen consumption peak
Time frame: Change from Baseline Oxygen consumption peak at 3 months
Blood pressure
Time frame: Change from Baseline Blood Pressure at 3 months
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 26 Sep 2017.
- Individual participant dataSharing planned: No
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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.
JF Lisón, Dr study director
University CEU Cardenal Herrera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based intervention with support, Web-based intervention without support and Traditional intervention in people with Child Obesity, run by Cardenal Herrera University at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 26 Sep 2017. 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 Spain. 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?
Percentage of body fat (time frame: Change from Baseline Percentage of body fat at 3 months). 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 26 Sep 2017.