Back to resultsEffects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Circuit training
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Children, Physical activity, Home-based treatment, Body mass index (z-BMI), Percentage body fat, Waist circumference
Eligibility Criteria
Inclusion Criteria:
- caucasian
- overweight/obese
Exclusion Criteria:
- Subjects with severe obesity (z-score above 2.5)
Sites / Locations
- Universidad CEU-Cardenal Herrera
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Hospital-based exercise program
Home-based exercise program
Control
Arm Description
Exercise monitored at the hospital
Participants perform exercise at home
Control Group participants maintained their usual levels of daily activity, with no additional exercise components.
Outcomes
Primary Outcome Measures
Body composition
body mass index (BMI), BMI-Z score
Secondary Outcome Measures
waist circumference
Percentage body fat
Full Information
NCT ID
NCT01503281
First Posted
January 3, 2012
Last Updated
January 11, 2012
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT01503281
Brief Title
Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
Official Title
Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Children, Physical activity, Home-based treatment, Body mass index (z-BMI), Percentage body fat, Waist circumference
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospital-based exercise program
Arm Type
Experimental
Arm Description
Exercise monitored at the hospital
Arm Title
Home-based exercise program
Arm Type
Experimental
Arm Description
Participants perform exercise at home
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Group participants maintained their usual levels of daily activity, with no additional exercise components.
Intervention Type
Other
Intervention Name(s)
Circuit training
Intervention Description
Aerobic and resistance training exercises + Mediterranean diet
Primary Outcome Measure Information:
Title
Body composition
Description
body mass index (BMI), BMI-Z score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
waist circumference
Time Frame
6 months
Title
Percentage body fat
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
caucasian
overweight/obese
Exclusion Criteria:
Subjects with severe obesity (z-score above 2.5)
Facility Information:
Facility Name
Universidad CEU-Cardenal Herrera
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
18463296
Citation
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.
Results Reference
background
PubMed Identifier
15896088
Citation
Watts 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.
Results Reference
background
PubMed Identifier
12811554
Citation
Deforche 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.
Results Reference
background
PubMed Identifier
22634075
Citation
Lison 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.
Results Reference
derived
Links:
URL
http://www.uchceu.es
Description
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.
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Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial
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