NCT06404619

Brief Summary

Healthy lifestyles are crucial for preventing chronic diseases. This study evaluated the effectiveness of mHealth intervention program in adopting healthy lifestyles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 23, 2024

Last Update Submit

May 3, 2024

Conditions

Keywords

lifestylemHealthnursing student

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    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.

    Assessed just before and immediately after the intervention

  • Blood Pressure Level assessed with the sphygmomanometer.

    Assessed just before and immediately after the intervention

Study Arms (2)

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.

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.

Behavioral: Education program

Interventions

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.

Traditional education programmHealth education program

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Nursing Princess Nourah bint Abdulrahman University

Riyadh, Saudi Arabia

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Shaherah Andargeery, MD

    College of Nursing, Princess Nourah bint Abdulrahman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 8, 2024

Study Start

August 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Between 12 and 36 months after article publication
Access Criteria
Data will be accessible to researchers to be used for systematic reviews or meta-analyses based on a reasonable request to the corresponding author.

Locations