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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Other: standard information; Other: positive information

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal weight; 30 normal weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise	Other: standard information; The participates will be given a standard information regarding the water drink before physical activity; 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
Active Comparator: Over weight; 30 over weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise	Other: standard information; The participates will be given a standard information regarding the water drink before physical activity; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Running time (seconds)	Overall running time during aerobic treadmill fitness test	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal heart rate (beats/min)	Maximal heart rate during aerobic treadmill fitness test	up to 6 weeks

Collaborators and Investigators

• Sponsor: Meir Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 3, 2018

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Childhood Obesity; Physical fitness; Information
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: MeirMc0017-17CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No