Clinical trial NCT03205293: School-Based Intervention Program to Promote Healthy Eating and Physical Activity
Official title: School-Based Intervention Program to Promote Healthy Eating and Physical Activity Using Participatory Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Childhood
Health Behavior
Physical Activity
Dietary Habits
Keywords: School-Based Intervention
Ecological Model
Participatory Approach
Palestinian Female Schoolchildren
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized control program trial, pre-post study
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* East Jerusalem Female Schoolchildren

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in percent of schoolchildren eating breakfast daily
timeFrame: At Baseline and 18 months after intervention
measure: Change in percent of schoolchildren performing physical activity for ≥ 5 days per week
timeFrame: At Baseline and 18 months after intervention
measure: Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables
timeFrame: At Baseline and 18 months after intervention
measure: Change in teachers' engagement
timeFrame: At Baseline and 18 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Donna Zwas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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