ObesityNCT01503281
Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
A study testing Circuit training in people with Obesity, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The aim of this study was to compare the effect of a hospital group-based vs. home-based combined exercise-diet program for the treatment of childhood obesity. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Circuit training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- caucasian
- overweight/obese
Who cannot join
- Subjects with severe obesity (z-score above 2.5)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare the effect of a hospital group-based vs. home-based combined exercise-diet program for the treatment of childhood obesity.
- Conditions
- Obesity
- Being tested
- Circuit training
- Keywords
- Children, Physical activity, Home-based treatment, Body mass index (z-BMI), Percentage body fat, Waist circumference
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit trainingOther
Aerobic and resistance training exercises + Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based exercise program | Experimental | Exercise monitored at the hospital Receives: Other: Circuit training |
| Home-based exercise program | Experimental | Participants perform exercise at home Receives: Other: Circuit training |
| Control | No intervention | Control Group participants maintained their usual levels of daily activity, with no additional exercise components. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
body mass index (BMI), BMI-Z score
Measured: 6 months
Secondary outcomes (2)
waist circumference
Measured: 6 months
Percentage body fat
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503281
- Sponsor's protocol ID
- CEU-UCH-95
- Status last verified
- Jan 2011
- First submitted
- 3 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Conwell LS, Trost SG, Spence L, Brown WJ, Batch JA. The feasibility of a home-based moderate-intensity physical activity intervention in obese children and adolescents. Br J Sports Med. 2010 Mar;44(4):250-5. doi: 10.1136/bjsm.2008.046359. Epub 2008 May 7.
PubMed 18463296Watts K, Jones TW, Davis EA, Green D. Exercise training in obese children and adolescents: current concepts. Sports Med. 2005;35(5):375-92. doi: 10.2165/00007256-200535050-00002.
PubMed 15896088Deforche B, De Bourdeaudhuij I, Debode P, Vinaimont F, Hills AP, Verstraete S, Bouckaert J. Changes in fat mass, fat-free mass and aerobic fitness in severely obese children and adolescents following a residential treatment programme. Eur J Pediatr. 2003 Sep;162(9):616-22. doi: 10.1007/s00431-003-1247-2. Epub 2003 Jun 13.
PubMed 12811554Lison JF, Real-Montes JM, Torro I, Arguisuelas MD, Alvarez-Pitti J, Martinez-Gramage J, Aguilar F, Lurbe E. Exercise intervention in childhood obesity: a randomized controlled trial comparing hospital-versus home-based groups. Acad Pediatr. 2012 Jul-Aug;12(4):319-25. doi: 10.1016/j.acap.2012.03.003. Epub 2012 May 26.
PubMed 22634075
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01503281
- Acronym / sponsor ID
- CEU-UCH-95
- Conditions
- Obesity
- Keywords
- Children, Physical activity, Home-based treatment, Body mass index (z-BMI), Percentage body fat, Waist circumference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- First posted
- 4 Jan 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 aim of this study was to compare the effect of a hospital group-based vs. home-based combined exercise-diet program for the treatment of childhood obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hospital-based exercise program | Experimental | Other: Circuit trainingExercise monitored at the hospital |
| Home-based exercise program | Experimental | Other: Circuit trainingParticipants perform exercise at home |
| Control | No intervention | –Control Group participants maintained their usual levels of daily activity, with no additional exercise components. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- caucasian
- overweight/obese
Key exclusion criteria (1 listed)
- Subjects with severe obesity (z-score above 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 |
|---|---|---|
| Circuit trainingAerobic and resistance training exercises + Mediterranean diet | Other | Home-based exercise program, Hospital-based exercise program |
Primary outcome
Body composition
Time frame: 6 months
body mass index (BMI), BMI-Z score
2 secondary outcomes
waist circumference
Time frame: 6 months
Percentage body fat
Time frame: 6 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 12 Jan 2012.
- Background: PubMed 18463296Conwell LS, Trost SG, Spence L, Brown WJ, Batch JA. The feasibility of a home-based moderate-intensity physical activity intervention in obese children and adolescents. Br J Sports Med. 2010 Mar;44(4):250-5. doi: 10.1136/bjsm.2008.046359. Epub 2008 May 7.
- Background: PubMed 15896088Watts K, Jones TW, Davis EA, Green D. Exercise training in obese children and adolescents: current concepts. Sports Med. 2005;35(5):375-92. doi: 10.2165/00007256-200535050-00002.
- Background: PubMed 12811554Deforche B, De Bourdeaudhuij I, Debode P, Vinaimont F, Hills AP, Verstraete S, Bouckaert J. Changes in fat mass, fat-free mass and aerobic fitness in severely obese children and adolescents following a residential treatment programme. Eur J Pediatr. 2003 Sep;162(9):616-22. doi: 10.1007/s00431-003-1247-2. Epub 2003 Jun 13.
- Derived from this study: PubMed 22634075Lison JF, Real-Montes JM, Torro I, Arguisuelas MD, Alvarez-Pitti J, Martinez-Gramage J, Aguilar F, Lurbe E. Exercise intervention in childhood obesity: a randomized controlled trial comparing hospital-versus home-based groups. Acad Pediatr. 2012 Jul-Aug;12(4):319-25. doi: 10.1016/j.acap.2012.03.003. Epub 2012 May 26.
- The University CEU-Cardenal Herrera is the first private University in the Valencian Community. It belongs to the Foundation San Pablo-CEU and is the leading educational organization in Spain with 3 Universities all over Spain.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit training in people with 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 2 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 12 Jan 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 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?
Body composition (time frame: 6 months). 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 NCT01503281, which also lists 4 linked publications.
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 12 Jan 2012.