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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
standard information
positive information
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Physical fitness, Exercise, Childhood Obesity, Information

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Normal weight

Over weight

Arm Description

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

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

Outcomes

Primary Outcome Measures

Running time (seconds)
Overall running time during aerobic treadmill fitness test

Secondary Outcome Measures

Maximal heart rate (beats/min)
Maximal heart rate during aerobic treadmill fitness test

Full Information

First Posted
April 18, 2017
Last Updated
December 5, 2018
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03165604
Brief Title
The Effect of Information on Physical Fitness Measures and Training in Overweight Children
Official Title
The Effect of Information on Physical Fitness Measures and Training in Overweight Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Physical fitness, Exercise, Childhood Obesity, Information

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Subjects will be given the same drink (water) in different packaging
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal weight
Arm Type
Active Comparator
Arm Description
30 normal weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise
Arm Title
Over weight
Arm Type
Active Comparator
Arm Description
30 over weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise
Intervention Type
Other
Intervention Name(s)
standard information
Intervention Description
The participates will be given a standard information regarding the water drink before physical activity
Intervention Type
Other
Intervention Name(s)
positive information
Intervention Description
The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity
Primary Outcome Measure Information:
Title
Running time (seconds)
Description
Overall running time during aerobic treadmill fitness test
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Maximal heart rate (beats/min)
Description
Maximal heart rate during aerobic treadmill fitness test
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30630461
Citation
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.
Results Reference
derived

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

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