Eating Habits and Obesity in First and Second Grade School Children

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Israel Diabetes Association
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00995267
First received: October 14, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Childhood Obesity
Behavioral: parent-child interaction/activities based on Adler's methods

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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 [ Time Frame: first grade to third grade ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in BMI and waist circumference [ Time Frame: first grade to third grade ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: behavioral intervention
Intervention arm comprises 5 joint parent-child school-based nutritional activities and a 5-session parental workshop. The control arm will receive no intervention.
Behavioral: parent-child interaction/activities based on Adler's methods

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.


  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995267

Locations
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Israel Diabetes Association
Investigators
Principal Investigator: Tori Goldstein, MSC Hebew University Faculty of Medicine
Principal Investigator: Jeremy D Kark, MD PhD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Jeremy D. Kark MD PhD, Professor, Hebrew University-Hadassah School of Public Health
ClinicalTrials.gov Identifier: NCT00995267     History of Changes
Other Study ID Numbers: LBoo1-HMO-CTIL
Study First Received: October 14, 2009
Last Updated: October 14, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
childhood obesity
nutrition
exercise
Alfred Adler
schoolchildren
intervention study
community-based trial
parent-child interaction
nutritional behaviors

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014