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Physical ActivityNCT03143309

Physical Activity Intervention to Promote Walking Among Female University Students

A study testing Intervention in people with Physical Activity, run by Qassim University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 28 years, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
1 siteSaudi Arabia
Study dates
15 Mar 2017to 28 Dec 2017
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 18 to 28 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • female
  • student enrolled at Qassim University during 2016-2017 academic year
  • owns smartphone with internet access
  • willing to complete all study requirements

Who cannot join

  • Physical disability that precludes physical activity
  • Morbidly obese (Body Mass Index >45 kg/m2)
  • Physician recommendation not to exercise

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Qassim University

    Buraidah, Al-Qassim, 51452

Other trials in Saudi Arabia

About this study

Official title: WhatsApp Physical Activity Intervention to Promote Walking Among Female University Students in Al-Qassim, Saudi Arabia: A Randomized Controlled Trial.

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.

Read the 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.

Being tested
Intervention, Control
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    Also called Walking group

    Brief introductory session, pedometer instruction, daily pedometer use, and health messages delivered via WhatsApp 2-3 times per week.

  • ControlOther

    Also called Attention Control

    Non-health related messages delivered via WhatsApp 2-3 times per week.

Study groups in NCT03143309
Study groupRoleWhat they receive
Walking + WhatsAppExperimentalThe 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.
Receives: Behavioral: Intervention
WhatsApp OnlyActive comparatorThe control participants will be enrolled into a WhatsApp group. They will receive 2-3 non-health related messages per week via WhatsApp.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Walking

    Change in 7-day average steps. Measurement tool = Omron pedometer HJ-320

    Measured: Baseline to 3-month follow-up

Secondary outcomes (3)

  1. Self-reported walking

    Change between baseline and follow-up for walking minutes per week. Measurement tool = International Physical Activity Questionnaire (IPAQ)

    Measured: Baseline to 3-month follow-up

  2. Body Mass Index

    Change in BMI score between baseline and follow-up. Objective measurement of height and weight.

    Measured: Baseline to 3-month follow-up

  3. Barriers to weight management

    Change in number of barriers between baseline and follow-up. Measurement tool = Validated questionnaire.

    Measured: Baseline to 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study start15 Mar 2017
  3. Primary completion28 Dec 2017
  4. Study completion28 Dec 2017

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03143309
Sponsor's protocol ID
QassimU
Status last verified
Oct 2018
First submitted
3 May 2017
Last updated
30 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Physical Activity, run by Qassim 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 4 inclusion and 3 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 30 Oct 2018. 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?

Walking (time frame: Baseline to 3-month follow-up). 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 NCT03143309.

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 30 Oct 2018.

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