Obesity, ChildhoodNCT03205293
School-Based Intervention Program to Promote Healthy Eating and Physical Activity
A study testing Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren in people with Obesity, Childhood and Health Behavior, run by Hadassah Medical Organization.
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… Read more about this study
- Who is it for?
- Ages 4 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Health Behavior, Physical Activity
- What is being tested?
- Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- East Jerusalem Female Schoolchildren
Who cannot join
- None
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Childhood, Health Behavior, Physical Activity, Dietary Habits
- Being tested
- Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren
- Keywords
- School-Based Intervention, Ecological Model, Participatory Approach, Palestinian Female Schoolchildren
- Medical subject headings
- Pediatric Obesity, Health Behavior, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female SchoolchildrenBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Female Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model. Receives: Behavioral: Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren |
| Control Group | No intervention | Regular school curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Baseline and 18 months after intervention
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
Measured: At Baseline and 18 months after intervention
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
Measured: At Baseline and 18 months after intervention
Change in teachers' engagement
Change in teachers' engagement will be assessed through a self report questionnaire
Measured: At Baseline and 18 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Mar 2011
- Primary completion1 Dec 2021
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized control program trial, pre-post study
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna Zwas, MD, MPH, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205293
- Sponsor's protocol ID
- 2310SBI-HMO-CTIL
- Status last verified
- Apr 2023
- First submitted
- 28 Jun 2017
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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).
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.
PubMed 16617231Lobstein 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.
PubMed 15096099World 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.
Badran M, Laher I. Obesity in arabic-speaking countries. J Obes. 2011;2011:686430. doi: 10.1155/2011/686430. Epub 2011 Nov 24.
PubMed 22175002Al 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.
PubMed 17381946Currie 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.
World Health Organization. WHO AnthroPlus for Personal Computers Manual. Geneva: World Health Organization, 2007.
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.
PubMed 20441660Savige 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.
PubMed 17868479Alarcon 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.
PubMed 11472248Guasch-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.
PubMed 24886626Larson 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.
PubMed 19508930Dietary 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).
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).
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-Based Intervention Program to Promote Healthy Eating and Physical Activity Using Participatory Approach
- ClinicalTrials.gov ID
- NCT03205293
- Acronym / sponsor ID
- 2310SBI-HMO-CTIL
- Conditions
- Obesity, Childhood, Health Behavior, Physical Activity, Dietary Habits
- Keywords
- School-Based Intervention, Ecological Model, Participatory Approach, Palestinian Female Schoolchildren
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized control program trial, pre-post study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female SchoolchildrenFemale Schoolchildren, their mothers and teachers will be exposed to multiple interventions designed through a participatory approach, integrating the ecological model. |
| Control Group | No intervention | –Regular school curriculum |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- East Jerusalem Female Schoolchildren
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren | Behavioural | Intervention Group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- BackgroundWorld 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).
- Background: PubMed 16617231Wyatt 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.
- Background: PubMed 15096099Lobstein 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.
- BackgroundWorld 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.
- Background: PubMed 22175002Badran M, Laher I. Obesity in arabic-speaking countries. J Obes. 2011;2011:686430. doi: 10.1155/2011/686430. Epub 2011 Nov 24.
- Background: PubMed 17381946Al 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.
- BackgroundCurrie 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.
- BackgroundWorld Health Organization. WHO AnthroPlus for Personal Computers Manual. Geneva: World Health Organization, 2007.
- Background: PubMed 20441660Mikki 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.
- Background: PubMed 17868479Savige 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.
- Background: PubMed 11472248Alarcon 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.
- Background: PubMed 24886626Guasch-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Zwas, MD, MPH principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren in people with Obesity, Childhood and Health Behavior, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent of schoolchildren eating breakfast daily (time frame: At Baseline and 18 months after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205293, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.