- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03143309
Physical Activity Intervention to Promote Walking Among Female University Students
WhatsApp Physical Activity Intervention to Promote Walking Among Female University Students in Al-Qassim, Saudi Arabia: A Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Sedentary lifestyle is a major risk factor for chronic diseases. The majority of Saudi females do not meet a recommended level of physical activity.
Study Objective: To test the effect of a physical activity intervention on daily walking.
Study Design: Parallel group randomized controlled design among female university students.
Methods: Students will be randomly assigned to either the intervention or the control arm. WhatsApp groups (2 per arm) will be formed within each study arm for communications. The intervention participants will receive a brief (15-minute) orientation on diet, exercise, and benefits of keeping a healthy weight; each will be instructed to wear a pedometer every day for 12-weeks with a daily step goal of 8,000. They will receive 2-3 health-promotional (walking and diet) messages per week via WhatsApp; group interaction is optional. The control group participants will receive 2-3 non-health related messages per week. Average daily steps will be assessed in all participants at baseline and 3-month follow-up using a 7-day pedometer measurement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Al-Qassim
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Buraidah, Al-Qassim, Saudi Arabia, 51452
- Qassim University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female
- student enrolled at Qassim University during 2016-2017 academic year
- owns smartphone with internet access
- willing to complete all study requirements
Exclusion Criteria:
- Physical disability that precludes physical activity
- Morbidly obese (Body Mass Index >45 kg/m2)
- Physician recommendation not to exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Walking + WhatsApp
The participants assigned to the intervention group will be given a brief (15-minute) orientation where they learn about the importance of exercise, diet, and the benefits of weight reduction.
They will be given further instruction on the regular use of the pedometer.
They will be enrolled into a WhatsApp group.
They will receive 2-3 health-promotional (walking and diet) messages per week via WhatsApp.
|
Brief introductory session, pedometer instruction, daily pedometer use, and health messages delivered via WhatsApp 2-3 times per week.
Other Names:
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|
Active Comparator: WhatsApp Only
The control participants will be enrolled into a WhatsApp group.
They will receive 2-3 non-health related messages per week via WhatsApp.
|
Non-health related messages delivered via WhatsApp 2-3 times per week.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking
Time Frame: Baseline to 3-month follow-up
|
Change in 7-day average steps.
Measurement tool = Omron pedometer HJ-320
|
Baseline to 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported walking
Time Frame: Baseline to 3-month follow-up
|
Change between baseline and follow-up for walking minutes per week.
Measurement tool = International Physical Activity Questionnaire (IPAQ)
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Baseline to 3-month follow-up
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Body Mass Index
Time Frame: Baseline to 3-month follow-up
|
Change in BMI score between baseline and follow-up.
Objective measurement of height and weight.
|
Baseline to 3-month follow-up
|
|
Barriers to weight management
Time Frame: Baseline to 3-month follow-up
|
Change in number of barriers between baseline and follow-up.
Measurement tool = Validated questionnaire.
|
Baseline to 3-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Juliann Saquib, PhD, College of Medicine, Qassim 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
Other Study ID Numbers
- QassimU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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