NCT03080376

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

March 5, 2017

Last Update Submit

September 22, 2017

Conditions

Keywords

ExerciseWeb-based intervention

Outcome Measures

Primary Outcomes (1)

  • Percentage of body fat

    Percentage of body fat

    Change from Baseline Percentage of body fat at 3 months

Secondary Outcomes (3)

  • Hand strength

    Change from Baseline Hand strength at 3 months

  • Oxygen consumption peak

    Change from Baseline Oxygen consumption peak at 3 months

  • Blood pressure

    Change from Baseline Blood Pressure at 3 months

Study Arms (3)

Web-based intervention without support

EXPERIMENTAL

3 months Web-based intervention without support

Other: Web-based intervention without support

Web-based intervention with support

EXPERIMENTAL

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

Other: Web-based intervention with support

Traditional intervention

ACTIVE COMPARATOR

3 months of Printed-based intervention

Other: Traditional intervention

Interventions

Web-based combined aerobics and muscular strength exercises.

Web-based intervention with support

Web-based combined aerobics and muscular strength exercises.

Web-based intervention without support

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

Traditional intervention

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Overweight or obese children and adolescents

You may not qualify if:

  • Secondary obesity syndromes
  • Severe obesity (z score \> 2.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moncada

Valencia, 46113, Spain

Location

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • JF Lisón, Dr

    University CEU Cardenal Herrera

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine Department

Study Record Dates

First Submitted

March 5, 2017

First Posted

March 15, 2017

Study Start

March 1, 2017

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations