NCT03143309

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

May 3, 2017

Last Update Submit

October 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Walking

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

    Baseline to 3-month follow-up

Secondary Outcomes (3)

  • Self-reported walking

    Baseline to 3-month follow-up

  • Body Mass Index

    Baseline to 3-month follow-up

  • Barriers to weight management

    Baseline to 3-month follow-up

Study Arms (2)

Walking + WhatsApp

EXPERIMENTAL

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

WhatsApp Only

ACTIVE COMPARATOR

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

Interventions

InterventionBEHAVIORAL

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

Also known as: Walking group
Walking + WhatsApp
ControlOTHER

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

Also known as: Attention Control
WhatsApp Only

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qassim University

Buraidah, Al-Qassim, 51452, Saudi Arabia

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Juliann Saquib, PhD

    College of Medicine, Qassim University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 8, 2017

Study Start

March 15, 2017

Primary Completion

December 28, 2017

Study Completion

December 28, 2017

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations