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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03143309
Other study ID # QassimU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2017
Est. completion date December 28, 2017

Study information

Verified date October 2018
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a parallel group randomized controlled trial among female university students designed to test the effect of a physical activity intervention on daily walking. Both groups will receive messages 2-3 times per week via WhatsApp. Intervention group will receive orientation and wear a pedometer for the study period. The follow-up duration is 3 months.


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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date December 28, 2017
Est. primary completion date December 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 28 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention
Brief introductory session, pedometer instruction, daily pedometer use, and health messages delivered via WhatsApp 2-3 times per week.
Other:
Control
Non-health related messages delivered via WhatsApp 2-3 times per week.

Locations

Country Name City State
Saudi Arabia Qassim University Buraidah Al-Qassim

Sponsors (1)

Lead Sponsor Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walking Change in 7-day average steps. Measurement tool = Omron pedometer HJ-320 Baseline to 3-month follow-up
Secondary Self-reported walking Change between baseline and follow-up for walking minutes per week. Measurement tool = International Physical Activity Questionnaire (IPAQ) Baseline to 3-month follow-up
Secondary Body Mass Index Change in BMI score between baseline and follow-up. Objective measurement of height and weight. Baseline to 3-month follow-up
Secondary Barriers to weight management Change in number of barriers between baseline and follow-up. Measurement tool = Validated questionnaire. Baseline to 3-month follow-up
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