NCT01503281

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2011

First QC Date

January 3, 2012

Last Update Submit

January 11, 2012

Conditions

Keywords

ChildrenPhysical activityHome-based treatmentBody mass index (z-BMI)Percentage body fatWaist circumference

Outcome Measures

Primary Outcomes (1)

  • Body composition

    body mass index (BMI), BMI-Z score

    6 months

Secondary Outcomes (2)

  • waist circumference

    6 months

  • Percentage body fat

    6 months

Study Arms (3)

Hospital-based exercise program

EXPERIMENTAL

Exercise monitored at the hospital

Other: Circuit training

Home-based exercise program

EXPERIMENTAL

Participants perform exercise at home

Other: Circuit training

Control

NO INTERVENTION

Control Group participants maintained their usual levels of daily activity, with no additional exercise components.

Interventions

Aerobic and resistance training exercises + Mediterranean diet

Home-based exercise programHospital-based exercise program

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • caucasian
  • overweight/obese

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU-Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

Related Publications (4)

  • 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.

    PMID: 18463296BACKGROUND
  • 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.

    PMID: 15896088BACKGROUND
  • 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.

    PMID: 12811554BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 4, 2012

Last Updated

January 12, 2012

Record last verified: 2011-01

Locations