- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06150248
Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students in Saudi Arabia
Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students at Northern Border University in Saudi Arabia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hanan ALZAREA, Master
- Phone Number: +966505392397
- Email: alzarea.hanan@gmail.com
Study Contact Backup
- Name: Geeta Appannah, PhD
- Phone Number: +603-97692471
- Email: geeta@upm.edu.my
Study Locations
-
-
Selangor
-
Serdang, Selangor, Malaysia, 43400
- Recruiting
- Geeta Appannah
-
Contact:
- Hanan ALZAREA, Master
- Phone Number: +966505392397
- Email: alzarea.hanan@gmail.com
-
Contact:
- Geeta Appannah, PhD
- Phone Number: +603-97692471
- Email: geeta@upm.edu.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female undergraduate students.
- Saudi students.
- Aged between 18-24 years.
- Categorized with a BMI greater than 25.
Exclusion Criteria:
- Pregnant students
- Students with diseases on treatment such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases.
- Students with any medical condition who not allowed to do physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group: No Intervention
Participants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine).
|
They will have their regular curriculums and normal physical activity routine.
|
|
Other: Intervention group
Intervention group: Participants assigned to the intervention group will receive educational intervention program to improve their knowledge and promote lifestyle adherence in terms of healthy diet behaviour and physical activity among the undergraduate students. This program will include educational booklets and educational classes include six weeks of in-person education sessions and six weeks of social media messaging. The course will include six weekly teaching units (lectures and group discussions, 45-60 minutes each): Topic 1: To understand the causes and prevention strategies for overweight and obesity. Topic 2: To understand food based approaches to reduce or prevent overweight and obesity. Topic 3: To understand the importance of regular physical activity. Topic 4: To demonstrate how snacking can be a healthy habit. Topic 5: To learn how to read and interpret food labels. Topic 6: To understand how to prepare healthy meals. |
This intervention is based on the Social Cognitive Theory (SCT) and The Health Belief Model (HBM) to improve knowledge and promote lifestyle adherence in terms of healthy diet behaviour and physical activity among the undergraduate students. This program will include educational booklets and educational classes include six weeks of in-person education sessions and six weeks of social media messaging. The course will include six weekly teaching units (lectures and group discussions, 45-60 minutes each): Topic 1: To understand the causes and prevention strategies for overweight and obesity. Topic 2: To understand food based approaches to reduce or prevent overweight and obesity. Topic 3: To understand the importance of regular physical activity. Topic 4: To demonstrate how snacking can be a healthy habit. Topic 5: To learn how to read and interpret food labels. Topic 6: To understand how to prepare healthy meals. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Improve Knowledge, Attitude and Practice of Obesity
Time Frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
The knowledge, attitude, and practice of obesity will be measured using a self-report instrument knowledge, attitudes, and practices questionnaire (KAPQ) modified by Laar et al. (2020).
The questionnaire will consist of close-ended questions divided into three sections: The knowledge section will cover participants' understanding of obesity, its causes, consequences, and prevention strategies.
The attitudes section will capture participants' feelings and opinions towards overweight obesity.
Some of the items under this section will include how participants feel about their body shape, weight, and diet.
The last section will capture participants' practices related to obesity, including the frequency of consumption of fast foods, sweets, refined carbohydrate foods, vegetables, and fruits.
|
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
|
2. Change the Body mass index (BMI)
Time Frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
The Body mass index (BMI) will be report in kg/m^2 by using the following formula (BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared).
Body weight will be measured using Omron HBF 375 to the nearest 0.1 kg.
SECA body meter 206 will be employed to measure their heights to the nearest 0.1 cm.
Body mass index (BMI) will be classified into (underweight, normal weight, overweight, and obesity).
If the BMI is less than 18.5, it falls within the underweight range.
If the BMI is 18.5 to <25, it falls within the healthy weight range.
If the BMI is 25.0 to <30, it falls within the overweight range.
If the BMI is 30.0 or higher, it falls within the obesity range.
|
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3. Improve the Physical Activity.
Time Frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
The Physical Activity will be measured using a self-report instrument international physical activity questionnaire (IPAQ).
The IPAQ was determined to be reliable (Craig et al., 2003) and valid (Lee et al., 2011).
It uses the types of intensity of physical activity and sitting time that people do as part of their daily lives to estimate the total physical activity per week and time spent sitting.
The IPAQ has seven open-ended questions surrounding the individuals' last 7-day recall of vigorous, moderate and sedentary physical activities; frequency (in days per week) and duration (time per day).
Participants in the both groups will respond to the IPAQ at three points of the study (beginning, post-intervention and 3-month follow-up).
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[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
|
4. Change Dietary Intake, Dietary Quality, Diet and Eating Behavioural
Time Frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
The dietary intake, dietary quality and eating behaviour will be measured by using a self-report instrument a Saudi food frequency questionnaire (SFFQ).
The SFFQ captures the frequency of consumption (number of times per week) and quantity of foods consumed (serving sizes) by participants over the past 12 months.
It includes 140 food items that include a variety of meats, bread and cereals, sandwiches and burgers, dairy products, sweets and meats, drinks, fruits and vegetables.
The questionnaire has 61 questions related to food consumption.
In addition, a 24-hour dietary recall (24HR-DR) questionnaire will be used.
The participants will name all foods consumed in the past 24 hours, the source of foods, the quantities of foods, method of preparation as well as the time of the day the foods were consumed.
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[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
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5. Improve Disordered Eating
Time Frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
The disordered eating will be measured by using a self-report instrument Eating attitude test 26 (EAT-26) a questionnaire.
The questionnaire comprised 2 main sections including the Eating attitude test 26 to measured weight concerns and abnormal eating.
Also, including an additional 5 eating behaviors questions.
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[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
|
6. Change Sedentary Activity
Time Frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
Sedentary Activity will be measured by using a self-report instrument the Sedentary Activity Questionnaire (SAQ).
The questionnaire will ask the participants how many hours and minutes they spent in eleven different sedentary behaviours per day on weekdays and weekends.
The questionnaire classified the eleven sedentary behaviours into five categories (Screen time, education, travel, cultural activities and social activities).
Participants indicate high sedentary behaviour if the total time of (SAQ) 4 hrs/day, while < 4 hrs/day means low sedentary behaviour.
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[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Geeta Appannah, PhD, Department of Nutrition , Faculty of Medicine and Health Sciences, UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UPM-PhD Hanan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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