The Effect of Information on Physical Fitness Measures and Training in Overweight Children
1 other identifier
interventional
54
1 country
1
Brief Summary
In the present study the investigators will examine the impact of varying information (positive compared to standard information) concerning a drink for improving physical fitness in overweight children.
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 Jul 2017
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
First Submitted
Initial submission to the registry
April 18, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2018
CompletedDecember 6, 2018
December 1, 2018
1.3 years
April 18, 2017
December 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Running time (seconds)
Overall running time during aerobic treadmill fitness test
up to 6 weeks
Secondary Outcomes (1)
Maximal heart rate (beats/min)
up to 6 weeks
Study Arms (2)
Normal weight
ACTIVE COMPARATOR30 normal weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise
Over weight
ACTIVE COMPARATOR30 over weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise
Interventions
The participates will be given a standard information regarding the water drink before physical activity
The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity
Eligibility Criteria
You may qualify if:
- Pre pubertal children
- Study group: BMI precentiles over 85 (overweight and obese children)
- Control group: BMI precentiles between 5-85 (normal weight children)
You may not qualify if:
- Children with organic Disease
- Competitive athlete
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center
Kfar Saba, 44281, Israel
Related Publications (1)
Fanti-Oren S, Birenbaum-Carmeli D, Eliakim A, Pantanowitz M, Nemet D. The effect of placebo on endurance capacity in normal weight children - a randomized trial. BMC Pediatr. 2019 Jan 10;19(1):15. doi: 10.1186/s12887-019-1394-x.
PMID: 30630461DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Nemet, MD
Meir Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Subjects will be given the same drink (water) in different packaging
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2017
First Posted
May 24, 2017
Study Start
July 1, 2017
Primary Completion
October 1, 2018
Study Completion
October 3, 2018
Last Updated
December 6, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share