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Home Exercise Intervention in Childhood Obesity

Primary Purpose

Child Obesity

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Web-based intervention with support

Web-based intervention without support

Traditional intervention

About this trial

This is an interventional treatment trial for Child Obesity focused on measuring Exercise, Web-based intervention

Eligibility Criteria

9 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Overweight or obese children and adolescents

Exclusion Criteria:

Secondary obesity syndromes
Severe obesity (z score > 2.5)

Sites / Locations

Moncada

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Web-based intervention without support

Web-based intervention with support

Traditional intervention

Arm Description

3 months Web-based intervention without support

3 months Web-based intervention with support (e-mails)

3 months of Printed-based intervention

Outcomes

Primary Outcome Measures

Percentage of body fat

Secondary Outcome Measures

Hand strength

Oxygen consumption peak

Blood pressure

Full Information

NCT ID

NCT03080376

First Posted

March 5, 2017

Last Updated

September 22, 2017

Sponsor

Cardenal Herrera University

1. Study Identification

Unique Protocol Identification Number

NCT03080376

Brief Title

Home Exercise Intervention in Childhood Obesity

Official Title

Home Exercise Intervention in Childhood Obesity: Randomized Clinical Trial Comparing Print-based Versus Web-based Platform

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

May 31, 2017 (Actual)

Study Completion Date

May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Child Obesity

Keywords

Exercise, Web-based intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Web-based intervention without support

Arm Type

Experimental

Arm Description

3 months Web-based intervention without support

Arm Title

Web-based intervention with support

Arm Type

Experimental

Arm Description

3 months Web-based intervention with support (e-mails)

Arm Title

Traditional intervention

Arm Type

Active Comparator

Arm Description

3 months of Printed-based intervention

Intervention Type

Other

Intervention Name(s)

Web-based intervention with support

Intervention Description

Web-based combined aerobics and muscular strength exercises.

Intervention Type

Other

Intervention Name(s)

Web-based intervention without support

Intervention Description

Web-based combined aerobics and muscular strength exercises.

Intervention Type

Other

Intervention Name(s)

Traditional intervention

Intervention Description

3 months of Printed-based combined aerobics and muscular strength exercise intervention.

Primary Outcome Measure Information:

Title

Percentage of body fat

Description

Percentage of body fat

Time Frame

Change from Baseline Percentage of body fat at 3 months

Secondary Outcome Measure Information:

Title

Hand strength

Description

Hand strength

Time Frame

Change from Baseline Hand strength at 3 months

Title

Oxygen consumption peak

Description

Oxygen consumption peak

Time Frame

Change from Baseline Oxygen consumption peak at 3 months

Title

Blood pressure

Description

Blood pressure

Time Frame

Change from Baseline Blood Pressure at 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Overweight or obese children and adolescents Exclusion Criteria: Secondary obesity syndromes Severe obesity (z score > 2.5)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JF Lisón, Dr

Organizational Affiliation

University CEU Cardenal Herrera

Official's Role

Study Director

Facility Information:

Facility Name

Moncada

City

Valencia

ZIP/Postal Code

46113

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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Home Exercise Intervention in Childhood Obesity

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