Clinical trial NCT06150248: Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students in Saudi Arabia
Official title: Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students at Northern Border University in Saudi Arabia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Physical Inactivity
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Northern Border University
First posted: 2023-11-29
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cluster randomized controlled trial (RCT) design
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1. Improve Knowledge, Attitude and Practice of Obesity
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
measure: 2. Change the Body mass index (BMI)
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
Secondary outcomes:
measure: 3. Improve the Physical Activity.
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
measure: 4. Change Dietary Intake, Dietary Quality, Diet and Eating Behavioural
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
measure: 5. Improve Disordered Eating
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
measure: 6. Change Sedentary Activity
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Geeta Appannah
state: Selangor
Study officials:
affiliation: Department of Nutrition , Faculty of Medicine and Health Sciences, UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
name: Geeta Appannah, PhD
role: STUDY_CHAIR
References: