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Eating Habits and Obesity in First and Second Grade School Children

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
parent-child interaction/activities based on Adler's methods
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring childhood obesity, nutrition, exercise, Alfred Adler, schoolchildren, intervention study, community-based trial, parent-child interaction, nutritional behaviors

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All children in regular first grade classes in 4 schools whose parents provided informed consent

Exclusion Criteria:

  • Schools with separate classes for boys and girls, and schools/classes for children with special needs

Sites / Locations

  • Hadassah University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

behavioral intervention

control arm

Arm Description

Behavioral intervention arm comprises 5 joint parent-child school-based nutritional activities in which nutritional information was combined with Adler's behavioral concepts. and a 5-session parental workshop.

Outcomes

Primary Outcome Measures

Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks

Secondary Outcome Measures

change in BMI and waist circumference

Full Information

First Posted
October 14, 2009
Last Updated
June 11, 2018
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00995267
Brief Title
Eating Habits and Obesity in First and Second Grade School Children
Official Title
The Influence of the Family as Agents of Change on Eating Habits and Obesity in First and Second Grade School Children in Israel.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose: In the framework of a randomized concurrent controlled trial, to assess the effectiveness of a feasible educational mechanism based on the principles of Alfred Adler, that focuses on the family, to improve the dietary habits of schoolchildren, to induce them to increase their physical activity, and to prevent obesity and diseases related to obesity. Primary Objectives for Children: 1.To increase intake of fruits and vegetables, to reduce intake of sweets and unhealthy snacks at home and in school, to increase exercise and to reduce sedentary activities. Primary Objective for the Parents: Increase the involvement of parents in the education of their children regarding nutrition. Description: Study population: Approximately 600 students and 600 parents from 24 first grade classes in 4 schools. Schools are randomized into intervention and control groups. The intervention comprises a 5-session parental workshop and 5 joint parent-child school-based activities. The control group will be offered the intervention after conclusion of the trial. Participants are recruited in first grade, anthropometrics are measured, and pupils and parents are interviewed on eating habits and exercise. Snacks are observed. The intervention takes place in the second grade, and outcome assessment is done at the end of the 2nd grade and beginning of the 3rd grade. In-depth interviews will be conducted with parents of obese children. Significance: Most interventions geared to prevention of childhood obesity have failed dismally. A new approach that focuses on the parent-child interaction may be contributory.
Detailed Description
Of the 743 children in 23 2nd grade classes in 4 schools, parents provided informed consent for 508 (68%), and again for 432 (58%) at the 3rd grade follow-up. First stage of Recruiting 2007-2008: 3 first grade in each of 4 schools participating in the study. Total 12 classes. After the recruitment, initial data collection was conducted. 2008-2009: Allocation of students in 2nd grade from cycle 1 to intervention and control groups. Intervention in the experimental group. Data collection at the beginning and end of second grade. Recruiting new first grade classes (cycle 2), Primary data collection was conducted. 2009-2010: Completion of the follow-up cycle I. Last data collection at the beginning of the third grade. Allocation students 2nd grade from cycle 2 for intervention or control groups. Intervention in the experimental group of cycle 2. Data collection at the beginning and end of the second grade. 2010-2011: End of follow-up cycle 2. Collect data at the beginning of the third grade. Description of the Intervention: 5 joint parent-child classroom activities on the subject of nutrition, undertaken separately in the 12 intervention classes of the 4 clusters (ie. 60 sessions). 5 workshops based on the approach of Adler that were restricted to parents, undertaken separately in the evenings for the 12 intervention classes (ie 60 sessions). The control group (11 classes) had no intervention, but was identically monitored from first through third grade.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
childhood obesity, nutrition, exercise, Alfred Adler, schoolchildren, intervention study, community-based trial, parent-child interaction, nutritional behaviors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
behavioral intervention
Arm Type
Experimental
Arm Description
Behavioral intervention arm comprises 5 joint parent-child school-based nutritional activities in which nutritional information was combined with Adler's behavioral concepts. and a 5-session parental workshop.
Arm Title
control arm
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
parent-child interaction/activities based on Adler's methods
Intervention Description
Description of the Intervention: 5 joint classroom activities (parents and children together, involving children in food choices/food preparation-sense of belonging/decision making): 1. Healthy breakfasts and 10 o'clock snacks 2. Fats and oils in the diet, cooking methods, setting limits to oily food intake. 3. Fruit and vegetables in the daily diet, adults as role models. 4. Learning about food categories & pyramid, healthy eating and growth. 5. Limiting consumption of sweets and snacks. Workshop for Parents: Explaining nutritional needs of children; how to encourage good eating habits, how to deal with children's manipulations, providing tools to elicit change; use of food to attract parental attention; practical tools to deal with their children's eating habits/obesity/refusal to eat/chronic health problems/failure to grow; ways to prevent use of food as an answer to childhood frustrations.
Primary Outcome Measure Information:
Title
Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks
Time Frame
first grade to third grade
Secondary Outcome Measure Information:
Title
change in BMI and waist circumference
Time Frame
first grade to third grade

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All children in regular first grade classes in 4 schools whose parents provided informed consent Exclusion Criteria: Schools with separate classes for boys and girls, and schools/classes for children with special needs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tori Goldstein, MSC
Organizational Affiliation
Hebew University Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy D Kark, MD PhD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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Eating Habits and Obesity in First and Second Grade School Children

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