School-Based Intervention Program to Promote Healthy Eating and Physical Activity
Primary Purpose
Obesity, Childhood, Health Behavior, Physical Activity
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood focused on measuring School-Based Intervention, Ecological Model, Participatory Approach, Palestinian Female Schoolchildren
Eligibility Criteria
Inclusion Criteria:
- East Jerusalem Female Schoolchildren
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Female Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model.
Regular school curriculum
Outcomes
Primary Outcome Measures
Change in percent of schoolchildren eating breakfast daily
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
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
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
Change in teachers' engagement will be assessed through a self report questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03205293
First Posted
June 28, 2017
Last Updated
April 23, 2023
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT03205293
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Health Behavior, Physical Activity, Dietary Habits
Keywords
School-Based Intervention, Ecological Model, Participatory Approach, Palestinian Female Schoolchildren
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized control program trial, pre-post study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Female Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Regular school curriculum
Intervention Type
Behavioral
Intervention Name(s)
Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren
Primary Outcome Measure Information:
Title
Change in percent of schoolchildren eating breakfast daily
Description
Change in percent of schoolchildren eating breakfast will be assessed through a self report questionnaire based on the WHO's HBSC questionnaire
Time Frame
At Baseline and 18 months after intervention
Title
Change in percent of schoolchildren performing physical activity for ≥ 5 days per week
Description
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
Time Frame
At Baseline and 18 months after intervention
Title
Change in percent of schoolchildren consuming the recommended servings of fruits and vegetables
Description
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
Time Frame
At Baseline and 18 months after intervention
Title
Change in teachers' engagement
Description
Change in teachers' engagement will be assessed through a self report questionnaire
Time Frame
At Baseline and 18 months after intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female Schoolchildren, their mothers and teachers
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
East Jerusalem Female Schoolchildren
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Zwas, MD, MPH
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
World Health Organization. Diet, Nutrition and the Prevention of Chronic Disease. Geneva: World Health Organization, 2003. Available at: http://www.who.int/dietphysicalactivity/publications/trs916/en/ (accessed: January 16, 2016).
Results Reference
background
PubMed Identifier
16617231
Citation
Wyatt SB, Winters KP, Dubbert PM. Overweight and obesity: prevalence, consequences, and causes of a growing public health problem. Am J Med Sci. 2006 Apr;331(4):166-74. doi: 10.1097/00000441-200604000-00002.
Results Reference
background
PubMed Identifier
15096099
Citation
Lobstein T, Baur L, Uauy R; IASO International Obesity TaskForce. Obesity in children and young people: a crisis in public health. Obes Rev. 2004 May;5 Suppl 1:4-104. doi: 10.1111/j.1467-789X.2004.00133.x. No abstract available.
Results Reference
background
Citation
World Health Organization. The challenge of obesity in the WHO European Region and the strategies for response. Geneva: World Health Organization Regional Office for Europe, 2007.
Results Reference
background
PubMed Identifier
22175002
Citation
Badran M, Laher I. Obesity in arabic-speaking countries. J Obes. 2011;2011:686430. doi: 10.1155/2011/686430. Epub 2011 Nov 24.
Results Reference
background
PubMed Identifier
17381946
Citation
Al Sabbah H, Vereecken C, Kolsteren P, Abdeen Z, Maes L. Food habits and physical activity patterns among Palestinian adolescents: findings from the national study of Palestinian schoolchildren (HBSC-WBG2004). Public Health Nutr. 2007 Jul;10(7):739-46. doi: 10.1017/S1368980007665501. Epub 2007 Feb 22.
Results Reference
background
Citation
Currie C, Hurrelmann K, Settertobulte W, Smith R TJ (editors). Health Behaviour in School-aged Children: a WHO Cross- National Study ( HBSC) International Report. Copenhagen: World Health Organization Regional Office for Europe; 2000.
Results Reference
background
Citation
World Health Organization. WHO AnthroPlus for Personal Computers Manual. Geneva: World Health Organization, 2007.
Results Reference
background
PubMed Identifier
20441660
Citation
Mikki N, Abdul-Rahim HF, Shi Z, Holmboe-Ottesen G. Dietary habits of Palestinian adolescents and associated sociodemographic characteristics in Ramallah, Nablus and Hebron governorates. Public Health Nutr. 2010 Sep;13(9):1419-29. doi: 10.1017/S1368980010000662. Epub 2010 May 4.
Results Reference
background
PubMed Identifier
17868479
Citation
Savige G, Macfarlane A, Ball K, Worsley A, Crawford D. Snacking behaviours of adolescents and their association with skipping meals. Int J Behav Nutr Phys Act. 2007 Sep 17;4:36. doi: 10.1186/1479-5868-4-36.
Results Reference
background
PubMed Identifier
11472248
Citation
Alarcon de la Lastra C, Barranco MD, Motilva V, Herrerias JM. Mediterranean diet and health: biological importance of olive oil. Curr Pharm Des. 2001 Jul;7(10):933-50. doi: 10.2174/1381612013397654.
Results Reference
background
PubMed Identifier
24886626
Citation
Guasch-Ferre M, Hu FB, Martinez-Gonzalez MA, Fito M, Bullo M, Estruch R, Ros E, Corella D, Recondo J, Gomez-Gracia E, Fiol M, Lapetra J, Serra-Majem L, Munoz MA, Pinto X, Lamuela-Raventos RM, Basora J, Buil-Cosiales P, Sorli JV, Ruiz-Gutierrez V, Martinez JA, Salas-Salvado J. Olive oil intake and risk of cardiovascular disease and mortality in the PREDIMED Study. BMC Med. 2014 May 13;12:78. doi: 10.1186/1741-7015-12-78.
Results Reference
background
PubMed Identifier
19508930
Citation
Larson NI, Neumark-Sztainer D, Harnack L, Wall M, Story M, Eisenberg ME. Calcium and dairy intake: Longitudinal trends during the transition to young adulthood and correlates of calcium intake. J Nutr Educ Behav. 2009 Jul-Aug;41(4):254-60. doi: 10.1016/j.jneb.2008.05.001.
Results Reference
background
Citation
Dietary Guidelines for American 2005. U.S Department of Health and Human Services. Department of Agriculture. Available at: http://health.gov/dietaryguidelines/dga2005/document/pdf/dga2005.pdf (accessed: January 16, 2016).
Results Reference
background
Citation
World Health Organization. Young People's Health in Context. Health Behaviour in School-aged Children (HBSC) Study: International Report from the 2001/2002 Survey. World Health Organization/ Europe. Available at: http://www.euro.who.int/en/publications/abstracts/young-peoples-health-in-context.- health-behaviour-in-school-aged-children-hbsc-study-international-report-from-the- 20012002-survey (accessed: January 18, 2016).
Results Reference
background
PubMed Identifier
14995052
Citation
Rolls BJ, Ello-Martin JA, Tohill BC. What can intervention studies tell us about the relationship between fruit and vegetable consumption and weight management? Nutr Rev. 2004 Jan;62(1):1-17. doi: 10.1111/j.1753-4887.2004.tb00001.x.
Results Reference
background
Citation
I.TETENS and S. ALINIA. The role of fruit consumption in the prevention of obesity. J Hortic Sci Biotechnol 2009;84:47-51.
Results Reference
background
Citation
World Health Organization. Global Recommendations on Physical Activity for Health.Geneva : World Health Organization. Geneva, 2010. Available from: http://www.who.int/dietphysicalactivity/factsheet_recommendations/en/(accessed: February 11, 2016).
Results Reference
background
PubMed Identifier
11158483
Citation
American Academy of Pediatrics. Committee on Public Education. American Academy of Pediatrics: Children, adolescents, and television. Pediatrics. 2001 Feb;107(2):423-6. doi: 10.1542/peds.107.2.423.
Results Reference
background
Citation
Kanao BJ, Abu-Nada OS, Zabut BM. Nutritional status correlated with sociodemographic and economic factors among preparatory school-aged children in the Gaza Strip. J Public Health 2008;17:113-9.
Results Reference
background
PubMed Identifier
20675716
Citation
Jildeh C, Papandreou C, Abu Mourad T, Hatzis C, Kafatos A, Qasrawi R, Philalithis A, Abdeen Z. Assessing the nutritional status of Palestinian adolescents from East Jerusalem: a school-based study 2002-03. J Trop Pediatr. 2011 Feb;57(1):51-8. doi: 10.1093/tropej/fmq042. Epub 2010 Jul 31.
Results Reference
background
PubMed Identifier
17284729
Citation
Temple JL, Giacomelli AM, Kent KM, Roemmich JN, Epstein LH. Television watching increases motivated responding for food and energy intake in children. Am J Clin Nutr. 2007 Feb;85(2):355-61. doi: 10.1093/ajcn/85.2.355.
Results Reference
background
PubMed Identifier
22704042
Citation
Veldhuis L, Vogel I, Renders CM, van Rossem L, Oenema A, HiraSing RA, Raat H. Behavioral risk factors for overweight in early childhood; the 'Be active, eat right' study. Int J Behav Nutr Phys Act. 2012 Jun 15;9:74. doi: 10.1186/1479-5868-9-74.
Results Reference
background
PubMed Identifier
23165544
Citation
Ouwens MA, Cebolla A, van Strien T. Eating style, television viewing and snacking in pre-adolescent children. Nutr Hosp. 2012 Jul-Aug;27(4):1072-8. doi: 10.3305/nh.2012.27.4.5805.
Results Reference
background
PubMed Identifier
21836174
Citation
Pate RR, Mitchell JA, Byun W, Dowda M. Sedentary behaviour in youth. Br J Sports Med. 2011 Sep;45(11):906-13. doi: 10.1136/bjsports-2011-090192.
Results Reference
background
PubMed Identifier
19106320
Citation
McDonald CM, Baylin A, Arsenault JE, Mora-Plazas M, Villamor E. Overweight is more prevalent than stunting and is associated with socioeconomic status, maternal obesity, and a snacking dietary pattern in school children from Bogota, Colombia. J Nutr. 2009 Feb;139(2):370-6. doi: 10.3945/jn.108.098111. Epub 2008 Dec 23.
Results Reference
background
PubMed Identifier
21218730
Citation
Mirmiran P, Sherafat-Kazemzadeh R, Jalali-Farahani S, Azizi F. Childhood obesity in the Middle East: a review. East Mediterr Health J. 2010 Sep;16(9):1009-17.
Results Reference
background
PubMed Identifier
23283503
Citation
Neuman M, Kawachi I, Gortmaker S, Subramanian SV. Urban-rural differences in BMI in low- and middle-income countries: the role of socioeconomic status. Am J Clin Nutr. 2013 Feb;97(2):428-36. doi: 10.3945/ajcn.112.045997. Epub 2013 Jan 2.
Results Reference
background
PubMed Identifier
16436107
Citation
Doak CM, Visscher TL, Renders CM, Seidell JC. The prevention of overweight and obesity in children and adolescents: a review of interventions and programmes. Obes Rev. 2006 Feb;7(1):111-36. doi: 10.1111/j.1467-789X.2006.00234.x.
Results Reference
background
PubMed Identifier
7635601
Citation
Hebert JR, Clemow L, Pbert L, Ockene IS, Ockene JK. Social desirability bias in dietary self-report may compromise the validity of dietary intake measures. Int J Epidemiol. 1995 Apr;24(2):389-98. doi: 10.1093/ije/24.2.389.
Results Reference
background
Learn more about this trial
School-Based Intervention Program to Promote Healthy Eating and Physical Activity
We'll reach out to this number within 24 hrs