Home Exercise Intervention in Childhood Obesity
1 other identifier
interventional
51
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
March 5, 2017
CompletedFirst Posted
Study publicly available on registry
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedSeptember 26, 2017
September 1, 2017
3 months
March 5, 2017
September 22, 2017
Conditions
Keywords
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
EXPERIMENTAL3 months Web-based intervention without support
Web-based intervention with support
EXPERIMENTAL3 months Web-based intervention with support (e-mails)
Traditional intervention
ACTIVE COMPARATOR3 months of Printed-based intervention
Interventions
Web-based combined aerobics and muscular strength exercises.
Web-based combined aerobics and muscular strength exercises.
3 months of Printed-based combined aerobics and muscular strength exercise intervention.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
JF Lisón, Dr
University CEU Cardenal Herrera
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