Back to resultsSpecially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Specially designed plates
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Childhood obesity, Plate, Food consumption
Eligibility Criteria
Inclusion Criteria:
- Over weight / obese children
- Normal weight children
Exclusion Criteria:
- Organic disease that cause obesity
- Underweight children (BMI percentiles < 5)
Sites / Locations
- Meir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Normal weight
Overweight children
Arm Description
Normal weight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion.
Overweight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion.
Outcomes
Primary Outcome Measures
Caloric intake
The amount of food and drink consumed by the children will be evaluated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02166892
Brief Title
Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children
Official Title
The Effect of Specially Designed Eating Plates on Self-served Portions and Caloric Intake in Normal Weight and Overweight Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dan Nemet, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size normal plates.
Detailed Description
40 normal weight and 40 overweight kindergarden and elementary school children will participate in this study.
Anthropometric measurements: weight, height, BMI and BMI percentiles will be measured and calculated for each participant.
The participants will take part in two non-exercise activities at the 'sport and health center for children and adolescence'. At the end of each activity, a lunch buffet that contains all food ingredients will be served. During one meeting the children will be handed a regular plate and at the second meeting they will be handed a specially designed plate (with marking of the recommended meal composition and portion).
The amount and composition of food on the plates will be assessed by weighing and photography before and after eating and analysed to report macronutrient consumption by a dietitian. The meetings for normal weight children will be separated from the overweight children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Childhood obesity, Plate, Food consumption
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal weight
Arm Type
Active Comparator
Arm Description
Normal weight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion.
Arm Title
Overweight children
Arm Type
Active Comparator
Arm Description
Overweight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion.
Intervention Type
Other
Intervention Name(s)
Specially designed plates
Primary Outcome Measure Information:
Title
Caloric intake
Description
The amount of food and drink consumed by the children will be evaluated.
Time Frame
Up to 1 hour after food serving
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Over weight / obese children
Normal weight children
Exclusion Criteria:
Organic disease that cause obesity
Underweight children (BMI percentiles < 5)
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
Country
Israel
12. IPD Sharing Statement
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Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children
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