- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06404619
Impact of mHealth Implementation Program on Improving Nursing Students' Lifestyle (mHealth)
Impact of mHealth Implementation Program on Improving Nursing Students' Lifestyle: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Riyadh, Saudi Arabia
- College of Nursing Princess Nourah bint Abdulrahman University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mHealth education program
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.
|
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.
|
|
Active Comparator: Traditional education program
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Assessed just before and immediately after the intervention
|
|
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.
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Assessed just before and immediately after the intervention
|
|
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).
|
Assessed just before and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Participants are categorized according to the BMI according to WHO into:
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Assessed just before and immediately after the intervention
|
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Blood Pressure Level assessed with the sphygmomanometer.
Time Frame: Assessed just before and immediately after the intervention
|
Participants are categorized according to their blood pressure into:
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Assessed just before and immediately after the intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Shaherah Andargeery, MD, College of Nursing, Princess Nourah bint Abdulrahman University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PNURSP2024R447
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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