School-Based Intervention Program to Promote Healthy Eating and Physical Activity

April 23, 2023 updated by: Donna R Zwas, Hadassah Medical Organization

School-Based Intervention Program to Promote Healthy Eating and Physical Activity Using Participatory Approach

The purpose of this research is to develop, apply, and evaluate a school-based intervention program in East Jerusalem schools, designed to increase knowledge and to improve the attitudes and healthy behavior of schoolchildren, their teachers and their mothers' with regard to healthy eating and physical activity habits. The study tested the hypothesis that the impact of the entire school intervention program on students' lifestyles is mediated by their teachers' engagement in health promotion and by their mothers' involvement in school activity.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled intervention program trial was carried out in 14 females' schools in East Jerusalem, selected randomly by a stratified sampling of four groups of schools. The primary target population was the students, while the secondary target populations were the mothers and the teachers at these schools. From the schools operating in East Jerusalem (Palestinian Authority, Jerusalem Municipality, private, and United Nations Relief and Works Agency) grades 4 and 5 were considered eligible to participate in the pre- and post-intervention studies.

The study process was designed, using the ecological model, in three stages; Stage one: Need assessment stage (pre-intervention, March-Jun 2011): A semi-structured interview was used with all 14 school principals, and a structured self-administered questionnaire was used with all teachers. A random sample of a 4th and 5th grade classes was selected, in which all mothers and their daughters were eligible to answer a self-administered questionnaire. The height and weight of the children were measured during this stage. These measurements were the baseline for assessing the current situation. In addition to school inspection tours was done to assess the school's health environment.

Stage two: Action stage (intervention, September 2011-June 2013): A random allocation of schools into intervention and control groups was done, followed by participatory planning and administration of the intervention in each of the 7 schools based on their needs assessments and assets. The program was implemented and administered by a steering committee in each of the schools, consisting of teachers, mothers, and children. Teachers underwent trainings in nutrition and physical activity. The program activities were monitored by regular visits twice a month. The implementation team met every four to six weeks to review the progress.

Stage three: Evaluation (post intervention, February-April 2013): Evaluation of the program was done after eighteen months of intervention using the same assessment questionnaires for both intervention and control schools among a different sample of children from grades 4 and 5, their mothers, and all of the teachers.

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • East Jerusalem Female Schoolchildren

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Female Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model.
Behavioral: Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren
No Intervention: Control Group
Regular school curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percent of schoolchildren eating breakfast daily
Time Frame: At Baseline and 18 months after intervention
Change in percent of schoolchildren eating breakfast will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
At Baseline and 18 months after intervention
Change in percent of schoolchildren performing physical activity for ≥ 5 days per week
Time Frame: At Baseline and 18 months after intervention
Change in percent of schoolchildren performing physical activity for ≥ 5 days per week will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
At Baseline and 18 months after intervention
Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables
Time Frame: At Baseline and 18 months after intervention
Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
At Baseline and 18 months after intervention
Change in teachers' engagement
Time Frame: At Baseline and 18 months after intervention
Change in teachers' engagement will be assessed through a self report questionnaire
At Baseline and 18 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Donna Zwas, MD, MPH, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

December 1, 2021

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2310SBI-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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