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NCT01503281 Clinical Trial

Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial

Obesity Clinical Trial

Official title:
Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01503281
Other study ID # CEU-UCH-95
Secondary ID
Status Completed
Phase N/A
First received January 3, 2012
Last updated January 11, 2012

Study information
Verified date January 2011
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- caucasian

- overweight/obese

Exclusion Criteria:

- Subjects with severe obesity (z-score above 2.5)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Circuit training
Aerobic and resistance training exercises + Mediterranean diet

Locations
Country Name City State
Spain Universidad CEU-Cardenal Herrera Moncada Valencia

Sponsors (1)
Lead Sponsor Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. Epub 2003 Jun 13. — View 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Body composition body mass index (BMI), BMI-Z score 6 months No
Secondary waist circumference 6 months No
Secondary Percentage body fat 6 months No
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