Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students in Saudi Arabia

Obesity Clinical Trial

Official title:

Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students at Northern Border University in Saudi Arabia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150248
• Other study ID #: UPM-PhD Hanan
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Universiti Putra Malaysia
• Contact: HANAN ALZAREA, Master
• Phone: +966505392397
• Email: alzarea.hanan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the World Health Organization (WHO), Saudi Arabia has seen a more astonishing rise in obesity. Young females have a considerable prevalence of unhealthy dietary practices and lack of knowledge about healthy and energy-dense foods. Additionally, in Saudi Arabia, the levels of physical inactivity ranged from about one-third to as high as 70% of the population. The current study aims to determine the effects of combined health education and motivational message intervention on promoting healthy lifestyles and body composition markers for undergraduate female students who suffer from obesity at Northern Border University in the Kingdom of Saudi Arabia.

Description:

A cluster randomized controlled study will be conducted among 250 undergraduate female students aged (18-24) in Northern Border University. The intervention and control faculties will be selected and allocated randomly. The intervention group will have six weeks of fortnightly six sessions (45 minutes), while the control group will have their regular curriculums and normal physical activity routine. The research instruments include socio-demographic characteristics, anthropometric measurements, and questionnaires about knowledge, attitude, and practice of obesity, physical activity, dietary intake, dietary quality, diet and eating behaviour, and disordered eating. Data will be collected from intervention and control groups at baseline, post-intervention, and 3-month follow-up after the intervention. Data will be analyzed by using the (SPSS) software version 26. Descriptive statistics will be used to distribute and summarize the data. A Generalized Estimating Equation (GEE) will be used to test the effect of the intervention program for the selected variables (outcomes) between and within the group at baseline, six weeks, and one month after intervention, which is adjusted for clustering.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Physical Inactivity

Intervention

Other:
• Education Intervention
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.
• No intervention
They will have their regular curriculums and normal physical activity routine.

Locations

Country	Name	City	State
Malaysia	Geeta Appannah	Serdang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	Northern Border University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Improve Knowledge, Attitude and Practice of Obesity	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)]]
Primary	2. Change the Body mass index (BMI)	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	3. Improve the Physical Activity.	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).	[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
Secondary	4. Change Dietary Intake, Dietary Quality, Diet and Eating Behavioural	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.	[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
Secondary	5. Improve Disordered Eating	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.	[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
Secondary	6. Change Sedentary Activity	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.	[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]