Clinical trial NCT00995267: 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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: childhood obesity
nutrition
exercise
Alfred Adler
schoolchildren
intervention study
community-based trial
parent-child interaction
nutritional behaviors
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 508
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

1. 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).
2. 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.

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

Primary outcomes:
measure: Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks
timeFrame: first grade to third grade
Secondary outcomes:
measure: change in BMI and waist circumference
timeFrame: first grade to third grade
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Hebew University Faculty of Medicine
name: Tori Goldstein, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Jeremy D Kark, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: