ObesityNCT06150248
Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students in Saudi Arabia
A study testing Education Intervention in people with Obesity and Physical Inactivity, run by Universiti Putra Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Inactivity
- What is being tested?
- Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female undergraduate students.
- Saudi students.
- Aged between 18-24 years.
- Categorized with a BMI greater than 25.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Geeta Appannah
Serdang, Selangor, 43400
Geeta Appannah, PhD, +603-97692471, geeta@upm.edu.my
Hanan ALZAREA, Master, +966505392397, alzarea.hanan@gmail.com
About this study
Official title: Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students at Northern Border University in Saudi Arabia
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.
Read the 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.
- Conditions
- Obesity, Physical Inactivity
- Being tested
- Education Intervention, No intervention
- Medical subject headings
- Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionOther
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 interventionOther
They will have their regular curriculums and normal physical activity routine.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | 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. Receives: Other: Education Intervention |
| Control group: No Intervention | Other | 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). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
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.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
Secondary outcomes (4)
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).
Measured: [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
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.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
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.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
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.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster randomized controlled trial (RCT) design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Border University
- Responsible party
- Principal investigator, Hanan Alzarea, Universiti Putra Malaysia
- Investigators
- Geeta Appannah, PhD, Study chair, Department of Nutrition , Faculty of Medicine and Health Sciences, UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150248
- Sponsor's protocol ID
- UPM-PhD Hanan
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students at Northern Border University in Saudi Arabia
- ClinicalTrials.gov ID
- NCT06150248
- Acronym / sponsor ID
- UPM-PhD Hanan
- Conditions
- Obesity, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Northern Border University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial (RCT) design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Education InterventionIntervention 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. |
| Control group: No Intervention | Other | Other: No interventionParticipants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine). |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female undergraduate students.
- Saudi students.
- Aged between 18-24 years.
- Categorized with a BMI greater than 25.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education InterventionThis 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. | Other | Intervention group |
| No interventionThey will have their regular curriculums and normal physical activity routine. | Other | Control group: No Intervention |
Primary outcome
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.
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.
4 secondary outcomes
3. Improve the Physical Activity.
Time frame: [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)]]
5. Improve Disordered Eating
Time frame: [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)]]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geeta Appannah, PhD study chair
Department of Nutrition , Faculty of Medicine and Health Sciences, UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention in people with Obesity and Physical Inactivity, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HANAN ALZAREA, Master (+966505392397, alzarea.hanan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.