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School Intervention Program to Promote Healthy Lifestyle Among Male Adolescent Students in King Faisal Residential City, Jeddah, Western Region, 2014-15

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ClinicalTrials.gov Identifier: NCT03885700
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

Brief Summary:

Through a cluster randomized control trial, 148 male adolescents' students were randomly assigned into either intervention group who received an educational program for two months (n=79), or control groups (n=69) who didn't attend the program. The principle outcomes were the changes in physical activities, consumption of healthy diet, sedentary life habits and anthropometric measurements. The outcomes of the intervention group were compared with their own baseline readings, as well as with the readings of the control group.

Rationale:

  • Saudi adolescents are in need for more exploration of their health problems and related health behaviors and application of intervention preventive services.
  • As a National Guard community medicine resident : I have a major interest in the health of adolescent and in fulfilling the aim of the school health programs of application of interventional preventive service that will target this vulnerable risky group.

Aim:

- Promote healthy life style among National Guard adolescents age group by application of interventional preventive program.

Objectives:

I. To measure physical activity patterns , sedentary behaviors and dietary habit among randomly selected adolescent in intervention and control group at National Guard Schools in Jeddah city 2014-2015.

II. To implement an interventional school promotional program among the school children from the addressed age group in 2014-2015.

III. To measure the effect of the interventional school promotional program among the two groups in relation to demographic, socioeconomic and other factors related to health in 2014-2015 .


Condition or disease Intervention/treatment Phase
Physical Activity Sedentary Behaviors Dietary Habits Obesity Behavioral: Educational program for 2 months Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: School Intervention Program to Promote Healthy Lifestyle Among Male Adolescent Students in King Faisal Residential City, Jeddah, Western Region, 2014-15
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : March 30, 2015
Actual Study Completion Date : March 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: intervention group Behavioral: Educational program for 2 months

The intervention was suggested based on the recommendations for adolescents' healthy diet and physical activity, it was derived from the 2008 Physical Activity Guidelines for Americans and Dietary Guidelines for Americans, 2010 by the U.S. HHS, Physical activity guidelines for children and adolescents by CPS 2012. The Food Guide Pyramid by the USDA, Nutrition &Healthy Eating by Mayo clinic & CDC website. The program was modified according to the age of the child. This plan was typically pursued in a School-based Intervention to Promote Healthy Lifestyles in Sousse, Tunisia, by Harrabi et al. The 1st month covered the healthy diet & the 2nd month covered the physical activity as follow:

  • 1st & 5th week: A 60-minutesession in health education.
  • 2nd & 6th week: Group counselling.
  • 3rd & 7th week: Students were divided into 8 groups & each group was asked to make presentation about a task related to the topic.
  • 4th & 8th week: Discussing the presentation.

No Intervention: control group



Primary Outcome Measures :
  1. Measurement of the Total Metabolic equivalents (METs) per week. [ Time Frame: 2 months ]
    • The Arab Teens Lifestyle Study Questionnaire was used to measures physical activity level.
    • This Questionnaire was designed to collect information on the:1- frequency 2- duration 3- intensity of a variety of physical activities during a typical week (e.g brisk walking for 20 minutes 3 times per week).
    • These activities were assigned metabolic equivalent (MET)values based on: the compendium of physical activity 2011.
    • Then for each activity the MET equation was applied, METs-min per week for specific activity = duration in min per day × number of days in which the activity were performed per week × METs of that activity (based on the compendium of physical activity 2011).
    • The total METs per week was calculated by combining the METs for all activities performed by each student in his regular week.

  2. measurement of the percentage of students who met the recommended activity level per week. [ Time Frame: 2 months ]
    • For the cut-off value the method used by Al-Hazzaa in his studies was followed, the minimal recommended physical activity per week is equal to 1680 METs.
    • student that had 1680 METs or higher per week were considered to be met the recommended physical activity per week.
    • student that had less than 1680 METs per week was considered to be physical inactive.
    • the percentage of students who met the recommended activity level per week was calculated.
    • the percentage of students who didn't met the recommended activity level per week was calculated.

  3. body weight measurement. [ Time Frame: 2 months ]
    - Tanita BC 418 was used to measure body weight in kg.

  4. height measurement. [ Time Frame: 2 months ]
    - the height was measured in cm using a validated measuring tape.

  5. Body Mass Index measurement. [ Time Frame: 2 months ]
    • the growth chart used by the Saudi Ministry of Health and which was developed by El Mouzan et al was used to plot the Height and weight on the chart to find the corresponding BMI in Kg/M^2 for each student.
    • the BMI categories for adolescents were defined according to the international definition of children's overweight and obesity developed by Cole et al. in 2000.

  6. body fat mass measurement. [ Time Frame: 2 months ]
    -Tanita BC 418 was used to measure body fat mass in Kg for each student.

  7. body fat percentage measurement. [ Time Frame: 2 months ]
    -Tanita BC 418 was used to measure body fat percentage for each student.

  8. measurement of the frequency of consumption of healthy and unhealthy food in regular week. [ Time Frame: 2 months. ]
    • The Arab Teens Lifestyle Study Questionnaire was used to measure dietary habits , as it asses the frequency of consumption of healthy and unhealthy food during regular week.
    • cut-off values :
    • For breakfast, fruit, vegetables, and milk daily consumption was considered as healthy dieting behavior as recommended by healthy food pyramids.
    • For fast food, the measure of three times or more per week was considered as unhealthy dieting behavior.
    • For soft drinks and remaining factors of unhealthy diet, the cut off value of three times per week or more was considered unhealthy dieting behavior.
    • Percentage of each of the healthy and unhealthy food consumption by students in regular week were calculated.

  9. measurement of the time spent daily in different sedentary behaviors. [ Time Frame: 2 months ]
    • The Arab Teens Lifestyle Study Questionnaire was used to measure the time in minutes spent in sedentary behaviors.
    • the allowed daily screen time per day as recommended by Canadian Sedentary Behavior Guidelines was no more than two hours of screen time per day.
    • percentage of student that exceeded the allowed daily screen time were calculated.



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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescent male students in the 5th grade and higher grades at King Faisal residential city schools in Jeddah.

Exclusion Criteria:

-

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Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT03885700    
Other Study ID Numbers: RJ14/014/J
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No