The Effect of Information on Physical Fitness Measures and Training in Overweight Children

NCT ID: NCT03165604

Last Updated: 2018-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-10-03

Brief Summary

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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.

Detailed Description

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The present study will explore the short and medium term effects of receiving information concerning a drink (water) (positive compared to standard information) on the physical fitness in overweight children.

Study subjects will be 30 overweight children aged 6 to 13, new participates in a nutritional, behavioral sport program,The control group of 30 normal weight children.

The first stage of the study the investigators will examine the short-term influence of different types of information concerning water on subjects' fitness which will be measured by treadmill performance. First, the water will be presented to the participants children as an ordinary water while in the second case it will be presented as an "energy drink".

The second stage of the study will examine the impact of varying information on the subjects' sports participation/level of physical activity over a 6 week period of training, Study subjects will be 30 over-weight children aged 6 to 13, who participate in a nutritional, behavioral sport program. During this period, information on the type of drink will be changed every week. Children will be assessed in all training sessions and their level of activity will be monitored to examine whether the information on the drink led to a different exercise behavior.

The study hypothesis is that the use of these positive information will increase participants' fitness and levels of activity compared to standard information.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Subjects will be given the same drink (water) in different packaging

Study Groups

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Normal weight

30 normal weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise

Group Type ACTIVE_COMPARATOR

standard information

Intervention Type OTHER

The participates will be given a standard information regarding the water drink before physical activity

positive information

Intervention Type OTHER

The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity

Over weight

30 over weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise

Group Type ACTIVE_COMPARATOR

standard information

Intervention Type OTHER

The participates will be given a standard information regarding the water drink before physical activity

positive information

Intervention Type OTHER

The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity

Interventions

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standard information

The participates will be given a standard information regarding the water drink before physical activity

Intervention Type OTHER

positive information

The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pre pubertal children
* Study group: BMI precentiles over 85 (overweight and obese children)
* Control group: BMI precentiles between 5-85 (normal weight children)

Exclusion Criteria

* Children with organic Disease
* Competitive athlete
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Nemet, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 30630461 (View on PubMed)

Other Identifiers

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MeirMc0017-17CTIL

Identifier Type: -

Identifier Source: org_study_id

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