Healthy LifestylemHealthNCT06404619
Impact of mHealth Implementation Program on Improving Nursing Students' Lifestyle
A study testing Education program in people with Healthy Lifestyle, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
Trial summary
Healthy lifestyles are crucial for preventing chronic diseases. This study evaluated the effectiveness of mHealth intervention program in adopting healthy lifestyles. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2023to 31 Dec 2023
- 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 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female nurse student
- aged 19-24 years
- with BMI ≥ 18.5
- capable of performing physical activity
- owner of a smartphone
- ready to use different social media
Who cannot join
- on diet regimen or have a history of diet regimen
- with history of chronic diseases e.g., DM, hypothyroidism or other endocrinal diseases
- with history of medications that may cause weight gain e.g., antipsychotics, antidepressants, antiepileptics or steroids
- with mental or psychological disorders
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Nursing Princess Nourah bint Abdulrahman University
Riyadh
About this study
Official title: Impact of mHealth Implementation Program on Improving Nursing Students' Lifestyle: A Randomized Controlled Trial
Healthy lifestyles are crucial for preventing chronic diseases. This study evaluated the effectiveness of mHealth intervention program in adopting healthy lifestyles.
Read the detailed description
Healthy lifestyles are crucial for preventing chronic diseases. Nonetheless, approximately 90% of university students regularly engage in at least one unhealthy lifestyle. Mobile smart devices-based health interventions (mHealth) that incorporate theoretical frameworks regarding behavioral change in interaction with the environment may provide an appealing and cost-effective approach for promoting sustainable adaptations of healthier lifestyles.
The aim of this study was to evaluate the effectiveness of mHealth intervention program compared to traditional (face-to-face) program in adopting healthy lifestyles among students of the Faculty of Nursing.
- Conditions
- Healthy Lifestyle
- Being tested
- Education program
- Keywords
- lifestyle, mHealth, nursing student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education programBehavioural
The message emphasizes the importance of quality of life and positive psychology. The concept of quality of life is described as multidimensional, also the message highlights the steps to change one's lifestyle, including self-reflection, habit modification, and commitment to a comprehensive lifestyle change include importance of physical activity, management of stress, quality and quantity of sleep and specific recommendations are provided regarding drinking water, organizing meals, and adopting a healthy balanced diet with attention to portion sizes. The message also discussed fitness foods that aid digestion and promote a healthy body. The message introduced the Healthy Eating Plate.
| Study group | Role | What they receive |
|---|---|---|
| mHealth education program | Experimental | They received 1 session every 2 weeks for 3 months using Zoom meeting (each session lasts for 1 hour). The message emphasizes the importance of quality of life and positive psychology and highlights the steps to change one's lifestyle, including self-reflection, habit modification, and commitment to a comprehensive lifestyle change include importance of physical activity, management of stress, quality and quantity of sleep and specific recommendations are provided regarding drinking water, organizing meals, and adopting a healthy balanced diet with attention to portion sizes. Daily engagement with the intervention was assessed using text message replies and number of coaching calls completed. Participants were asked to reply "Done" via Emails, Facebook, WhatsApp, Telegram, Instagram, or Zoom meeting. Receives: Behavioral: Education program |
| Traditional education program | Active comparator | They received 1 session every 2 weeks for 3 months at their convenience place (each session lasts for 1 hour). The same message as the Intervention group. Small group discussions and display of educational messages, posters, handout, and power point presentation lectures. Receives: Behavioral: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity time and levels of participants as assessed by Global/International Physical Activity Questionnaire (GPAQ/IPAQ).
The total weekly time spent on physical activity and the time spent in each domain (work, transportation, and recreational time) are determined by multiplying the number of days per week in each category by the average daily duration. Minutes per week in each category are then multiplied by metabolic equivalents (MET). The overall GPAQ score is described as "Low" if < 600 MET-minutes/week, "Moderate" if = 600-1500 MET-minutes/week, or "High" if > 1500 MET-minutes/week.
Measured: Assessed just before and immediately after the intervention
Dietary assessment using Food frequency questionnaire (FFQ).
It consists of 140 food items categorized under 27 categories with three Likert scale (usually eat, sometimes eat, and rarely eat). Score of 27-45 indicates bad healthy choices, 46-63 indicate fair healthy choices, and 64-81 indicate good healthy choices.
Measured: Assessed just before and immediately after the intervention
Sleep quality scale.
It assesses the quality of sleep for the last one month and consists of 28 questions with four Likert scale (rarely, sometimes, often, and almost always). The total score can range from 0 to 84, with higher scores demoting more more frequent sleep disturbances (Good quality of sleep ≤ 28, Fair 29 - ≤ 56, and poor > 56).
Measured: Assessed just before and immediately after the intervention
Secondary outcomes (2)
The weight in kilograms and height in meters will be combined to report the body mass index (BMI) in kg/m2.
Participants are categorized according to the BMI according to WHO into:
- Underweight (BMI < 18.5 kg/m2)
- Normal weight (BMI = 18.5 - 24.9 kg/m2)
- Overweight (BMI = 25 - 29.9 kg/m2)
- Obese (BMI ≥ 30 kg/m2)
Measured: Assessed just before and immediately after the intervention
Blood Pressure Level assessed with the sphygmomanometer.
Participants are categorized according to their blood pressure into:
- Normal blood pressure: Less than 120/80 mmHg
- At risk for high blood pressure (prehypertension): Between 120/80 and 140/90
- High blood pressure (hypertension): More than 140/90 mmHg
Measured: Assessed just before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaherah Andargeery, Princess Nourah Bint Abdulrahman University
- Investigators
- Shaherah Andargeery, MD, Principal investigator, College of Nursing, Princess Nourah bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404619
- Sponsor's protocol ID
- PNURSP2024R447
- Acronym
- mHealth
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the individual de-identified participants' data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 36 months following article publication.
Publications
Andargeery SY, El-Rafey DS. A randomized controlled trial of the effectiveness of the mHealth program in improving the lifestyle of nursing students. Sci Rep. 2025 Mar 21;15(1):9765. doi: 10.1038/s41598-024-80982-2.
PubMed 40118869
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of mHealth Implementation Program on Improving Nursing Students' Lifestyle: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06404619
- Acronym / sponsor ID
- mHealth / PNURSP2024R447
- Conditions
- Healthy Lifestyle
- Keywords
- lifestyle, mHealth, nursing student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 May 2024 (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.
Healthy lifestyles are crucial for preventing chronic diseases. This study evaluated the effectiveness of mHealth intervention program in adopting healthy lifestyles.
Detailed description
Healthy lifestyles are crucial for preventing chronic diseases. Nonetheless, approximately 90% of university students regularly engage in at least one unhealthy lifestyle. Mobile smart devices-based health interventions (mHealth) that incorporate theoretical frameworks regarding behavioral change in interaction with the environment may provide an appealing and cost-effective approach for promoting sustainable adaptations of healthier lifestyles.
The aim of this study was to evaluate the effectiveness of mHealth intervention program compared to traditional (face-to-face) program in adopting healthy lifestyles among students of the Faculty of Nursing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth education program | Experimental | Behavioral: Education programThey received 1 session every 2 weeks for 3 months using Zoom meeting (each session lasts for 1 hour). The message emphasizes the importance of quality of life and positive psychology and highlights the steps to change one's lifestyle, including self-reflection, habit modification, and commitment to a comprehensive lifestyle change include importance of physical activity, management of stress, quality and quantity of sleep and specific recommendations are provided regarding drinking water, organizing meals, and adopting a healthy balanced diet with attention to portion sizes. Daily engagement with the intervention was assessed using text message replies and number of coaching calls completed. Participants were asked to reply "Done" via Emails, Facebook, WhatsApp, Telegram, Instagram, or Zoom meeting. |
| Traditional education program | Active comparator | Behavioral: Education programThey received 1 session every 2 weeks for 3 months at their convenience place (each session lasts for 1 hour). The same message as the Intervention group. Small group discussions and display of educational messages, posters, handout, and power point presentation lectures. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male or female nurse student
- aged 19-24 years
- with BMI ≥ 18.5
- capable of performing physical activity
- owner of a smartphone
Key exclusion criteria (4 listed)
- on diet regimen or have a history of diet regimen
- with history of chronic diseases e.g., DM, hypothyroidism or other endocrinal diseases
- with history of medications that may cause weight gain e.g., antipsychotics, antidepressants, antiepileptics or steroids
- with mental or psychological disorders
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 programThe message emphasizes the importance of quality of life and positive psychology. The concept of quality of life is described as multidimensional, also the message highlights the steps to change one's lifestyle, including self-reflection, habit modification, and commitment to a comprehensive lifestyle change include importance of physical activity, management of stress, quality and quantity of sleep and specific recommendations are provided regarding drinking water, organizing meals, and adopting a healthy balanced diet with attention to portion sizes. The message also discussed fitness foods that aid digestion and promote a healthy body. The message introduced the Healthy Eating Plate. | Behavioural | Traditional education program, mHealth education program |
Primary outcome
Physical activity time and levels of participants as assessed by Global/International Physical Activity Questionnaire (GPAQ/IPAQ).
Time frame: Assessed just before and immediately after the intervention
The total weekly time spent on physical activity and the time spent in each domain (work, transportation, and recreational time) are determined by multiplying the number of days per week in each category by the average daily duration. Minutes per week in each category are then multiplied by metabolic equivalents (MET). The overall GPAQ score is described as "Low" if < 600 MET-minutes/week, "Moderate" if = 600-1500 MET-minutes/week, or "High" if > 1500 MET-minutes/week.
Dietary assessment using Food frequency questionnaire (FFQ).
Time frame: Assessed just before and immediately after the intervention
It consists of 140 food items categorized under 27 categories with three Likert scale (usually eat, sometimes eat, and rarely eat). Score of 27-45 indicates bad healthy choices, 46-63 indicate fair healthy choices, and 64-81 indicate good healthy choices.
Sleep quality scale.
Time frame: Assessed just before and immediately after the intervention
It assesses the quality of sleep for the last one month and consists of 28 questions with four Likert scale (rarely, sometimes, often, and almost always). The total score can range from 0 to 84, with higher scores demoting more more frequent sleep disturbances (Good quality of sleep ≤ 28, Fair 29 - ≤ 56, and poor > 56).
2 secondary outcomes
The weight in kilograms and height in meters will be combined to report the body mass index (BMI) in kg/m2.
Time frame: Assessed just before and immediately after the intervention
Blood Pressure Level assessed with the sphygmomanometer.
Time frame: Assessed just before and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40118869Andargeery SY, El-Rafey DS. A randomized controlled trial of the effectiveness of the mHealth program in improving the lifestyle of nursing students. Sci Rep. 2025 Mar 21;15(1):9765. doi: 10.1038/s41598-024-80982-2.
- Individual participant dataSharing planned: Yes. We will share the individual de-identified participants' data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 36 months following article publication.
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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.
Shaherah Andargeery, MD principal investigator
College of Nursing, Princess Nourah bint Abdulrahman University
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 program in people with Healthy Lifestyle, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 8 May 2024. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity time and levels of participants as assessed by Global/International Physical Activity Questionnaire (GPAQ/IPAQ). (time frame: Assessed just before and immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06404619, which also lists 1 linked publication.
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 8 May 2024.