Eating Habits and Obesity in First and Second Grade School Children

NCT00995267 | Completed DMC

• 1 other identifier: LBoo1-HMO-CTIL
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

childhood obesity; nutrition; exercise; Alfred Adler; schoolchildren; intervention study; community-based trial; parent-child interaction; nutritional behaviors

Outcome Measures

Primary Outcomes (1)

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

  first grade to third grade

Secondary Outcomes (1)

• change in BMI and waist circumference

  first grade to third grade

Study Arms (2)

behavioral intervention

EXPERIMENTAL

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.

Behavioral: parent-child interaction/activities based on Adler's methods

control arm

NO INTERVENTION

Interventions

parent-child interaction/activities based on Adler's methods BEHAVIORAL

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.

behavioral intervention

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tori Goldstein, MSC

  Hebew University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Jeremy D Kark, MD PhD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: June 12, 2018

Record last verified: 2009-10

Locations

IL (1)