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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03205293
Other study ID # 2310SBI-HMO-CTIL
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2011
Est. completion date December 1, 2024

Study information

Verified date April 2023
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date December 1, 2024
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 4 Years to 65 Years
Eligibility Inclusion Criteria: - East Jerusalem Female Schoolchildren Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

References & Publications (30)

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. — View 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. — View 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. — View Citation

Badran M, Laher I. Obesity in arabic-speaking countries. J Obes. 2011;2011:686430. doi: 10.1155/2011/686430. Epub 2011 Nov 24. — View 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.

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).

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. — View 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. — View 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. — View Citation

I.TETENS and S. ALINIA. The role of fruit consumption in the prevention of obesity. J Hortic Sci Biotechnol 2009;84:47-51.

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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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).

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).

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.

World Health Organization. WHO AnthroPlus for Personal Computers Manual. Geneva: World Health Organization, 2007.

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).

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. — View Citation

* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 At Baseline and 18 months after intervention
Primary 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 At Baseline and 18 months after intervention
Primary 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 At Baseline and 18 months after intervention
Primary Change in teachers' engagement Change in teachers' engagement will be assessed through a self report questionnaire At Baseline and 18 months after intervention
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