Physical Activity Intervention to Promote Walking Among Female University Students

October 29, 2018 updated by: Abdulrahman Al-Mohaimeed, Qassim University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Al-Qassim
      • Buraidah, Al-Qassim, Saudi Arabia, 51452
        • Qassim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Intervention
Brief introductory session, pedometer instruction, daily pedometer use, and health messages delivered via WhatsApp 2-3 times per week.
Other Names:
  • Walking group
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.
Other: Control
Non-health related messages delivered via WhatsApp 2-3 times per week.
Other Names:
  • Attention Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Baseline to 3-month follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qassim University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Juliann Saquib, PhD, College of Medicine, Qassim University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QassimU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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