NCT03657316

Brief Summary

Good health is an important indicator of the quality of life, in which healthy nutrition and physical activity take an important place. Healthy nutrition and physical activity according to the guidelines of WHO are closely related to lower general and specific mortality rates due to heart and coronary diseases and cancer, which are the top reasons for mortality from non-communicable diseases. Every year, 41 million people die from non-communicable diseases, which represents 71% of the total number of global deaths. This largely invisible epidemic is more serious in low- and middle-income countries, where 85% of non-communicable diseases premature deaths occur

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 6, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 30, 2018

Last Update Submit

September 4, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Dietary knowledge

    The level of nutrition knowledge will be determined using questions concerning nutrients and their functions, food sources, dietary needs and concept of balanced diet, healthy eating, diet-related health risks and diseases. Knowledge score will be calculated The level of nutrition knowledge will be determined using questions concerning nutrients and their functions, food sources, dietary needs and concept of balanced diet, healthy eating, diet-related health risks and diseases. • Nutrition attitude: Nutrition attitude will be assessed through questions including attitudes towards the importance of nutrition and developing healthy dietary habits. The subjects will be asked to state their level of agreement or disagreement with statements using a Likert scale. • Dietary practices: Dietary practices will be evaluated through food frequency questionnaire and questions on some dietary habits as regularity of meals and main type of snacks.

    5 months after the start of the intervention. immediately after end of the sustainable program

  • Nutrition attitude

    Nutrition attitude will be assessed through questions including attitudes towards the importance of nutrition and developing healthy dietary habits. The subjects will be asked to state their level of agreement or disagreement with statements using a Likert scale. Attitude score will be calculated

    5 months after the start of the intervention. immediately after end of the sustainable program

  • Dietary practices

    Dietary practices will be evaluated through food frequency questionnaire and questions on some dietary habits as regularity of meals and main type of snacks

    5 months after the start of the intervention. immediately after end of the sustainable program

Secondary Outcomes (1)

  • Body mass index

    5 months after the start of the intervention. immediately after end of the sustainable program

Study Arms (3)

experimental school 1

EXPERIMENTAL

The experimental school 1 will receive the following: * Nutritional and physical activity educational workshop * Enhanced physical education * Involvement of the morning broadcast * Educational brochure will be sent to the parents * A monthly telephone call or a text message will be sent to the parents * Message to school administration to prevent selling of soft drinks and to sell healthy food * A monthly session (3 months)

Behavioral: nutrition education

experimental school 2

EXPERIMENTAL

The experimental school 2 school will receive a nutritional and physical activity educational workshop; that will be held on three days through one week; one hour session each day

Behavioral: nutrition education

control

NO INTERVENTION

The control school will receive no intervention

Interventions

The content of the three days workshop:Healthy diet, Diet-related health risks and diseases, Physical activity The sustained multi-component program will be based on The three days nutritional and physical education workshop Enhanced physical education Involvement of the morning broadcast in provision of messages for students about nutrition and physical activity Brochure including key messages about diet and physical activity will be designed and sent to parents of the intervention classes of students A monthly telephone call or a text message will be sent to the parents to remind them about the commitment to the dietary health practices. Message to school administration to prevent selling of soft drinks and to sell healthy food A monthly session for three months will be held to remind the students with the messages

experimental school 1experimental school 2

Eligibility Criteria

Age11 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Second year preparatory school female students in Assiut city.
  • A group of female preparatory school students' mothers will be invited to participate in focus groups discussions from each school.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

Related Publications (9)

  • Collins CE, Dewar DL, Schumacher TL, Finn T, Morgan PJ, Lubans DR. 12 month changes in dietary intake of adolescent girls attending schools in low-income communities following the NEAT Girls cluster randomized controlled trial. Appetite. 2014 Feb;73:147-55. doi: 10.1016/j.appet.2013.11.003. Epub 2013 Nov 12.

    PMID: 24239513BACKGROUND
  • Ali HI, Ng SW, Zaghloul S, Harrison GG, Qazaq HS, El Sadig M, Yeatts K. High proportion of 6 to 18-year-old children and adolescents in the United Arab Emirates are not meeting dietary recommendations. Nutr Res. 2013 Jun;33(6):447-56. doi: 10.1016/j.nutres.2013.03.008. Epub 2013 May 4.

    PMID: 23746560BACKGROUND
  • Amaya-Castellanos C, Shamah-Levy T, Escalante-Izeta E, Morales-Ruan Mdel C, Jimenez-Aguilar A, Salazar-Coronel A, Uribe-Carvajal R, Amaya-Castellanos A. Development of an educational intervention to promote healthy eating and physical activity in Mexican school-age children. Eval Program Plann. 2015 Oct;52:159-68. doi: 10.1016/j.evalprogplan.2015.05.002. Epub 2015 Jun 11.

    PMID: 26099561BACKGROUND
  • Fahlman MM, Dake JA, McCaughtry N, Martin J. A pilot study to examine the effects of a nutrition intervention on nutrition knowledge, behaviors, and efficacy expectations in middle school children. J Sch Health. 2008 Apr;78(4):216-22. doi: 10.1111/j.1746-1561.2008.00289.x.

    PMID: 18336681BACKGROUND
  • Hassan-Wassef H. Food habits of the Egyptians: newly emerging trends. East Mediterr Health J. 2004 Nov;10(6):898-915.

    PMID: 16335778BACKGROUND
  • Murimi MW, Kanyi M, Mupfudze T, Amin MR, Mbogori T, Aldubayan K. Factors Influencing Efficacy of Nutrition Education Interventions: A Systematic Review. J Nutr Educ Behav. 2017 Feb;49(2):142-165.e1. doi: 10.1016/j.jneb.2016.09.003. Epub 2016 Nov 1.

    PMID: 27814976BACKGROUND
  • Musaiger AO, Al-Mannai M, Tayyem R, Al-Lalla O, Ali EY, Kalam F, Benhamed MM, Saghir S, Halahleh I, Djoudi Z, Chirane M. Perceived barriers to healthy eating and physical activity among adolescents in seven Arab countries: a cross-cultural study. ScientificWorldJournal. 2013 Nov 14;2013:232164. doi: 10.1155/2013/232164. eCollection 2013.

    PMID: 24348144BACKGROUND
  • Perez-Rodrigo C, Aranceta J. School-based nutrition education: lessons learned and new perspectives. Public Health Nutr. 2001 Feb;4(1A):131-9. doi: 10.1079/phn2000108.

    PMID: 11255503BACKGROUND
  • Shah P, Misra A, Gupta N, Hazra DK, Gupta R, Seth P, Agarwal A, Gupta AK, Jain A, Kulshreshta A, Hazra N, Khanna P, Gangwar PK, Bansal S, Tallikoti P, Mohan I, Bhargava R, Sharma R, Gulati S, Bharadwaj S, Pandey RM, Goel K. Improvement in nutrition-related knowledge and behaviour of urban Asian Indian school children: findings from the 'Medical education for children/Adolescents for Realistic prevention of obesity and diabetes and for healthy aGeing' ( MARG) intervention study. Br J Nutr. 2010 Aug;104(3):427-36. doi: 10.1017/S0007114510000681. Epub 2010 Apr 7.

    PMID: 20370939BACKGROUND

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Dalia Mohamed Atef Shehata, MSC

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Farag Mohamed Moftah, PHD

CONTACT

Dalia Galal Mahran, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 5, 2018

Study Start

September 1, 2019

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

September 6, 2018

Record last verified: 2018-08

Locations