School-Based Intervention Program to Promote Healthy Eating and Physical Activity
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| ClinicalTrials.gov Identifier: NCT03205293 |
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Recruitment Status :
Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : June 21, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity, Childhood Health Behavior Physical Activity Dietary Habits | Behavioral: Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 1500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a randomized control program trial, pre-post study |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | School-Based Intervention Program to Promote Healthy Eating and Physical Activity Using Participatory Approach |
| Actual Study Start Date : | March 1, 2011 |
| Actual Primary Completion Date : | December 1, 2021 |
| Estimated Study Completion Date : | December 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention Group
Female Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model.
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Behavioral: Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren |
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No Intervention: Control Group
Regular school curriculum
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- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | 4 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Female Schoolchildren, their mothers and teachers |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- East Jerusalem Female Schoolchildren
Exclusion Criteria:
- None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205293
| Principal Investigator: | Donna Zwas, MD, MPH | Hadassah Medical Organization |
| Responsible Party: | Donna R Zwas, Director of Linda Joy Pollin Cardiovascular Wellness Center for Women, Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT03205293 |
| Other Study ID Numbers: |
2310SBI-HMO-CTIL |
| First Posted: | July 2, 2017 Key Record Dates |
| Last Update Posted: | June 21, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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School-Based Intervention Ecological Model Participatory Approach Palestinian Female Schoolchildren |
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Pediatric Obesity Obesity Overnutrition |
Nutrition Disorders Overweight Body Weight |