Condition category
Not Applicable
Date applied
19/12/2019
Date assigned
05/03/2020
Last edited
05/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Despite the health benefits, physical activity levels among adults in Jordan are low. The aim of this study was to investigate whether a behavioural intervention could increase physical activity levels, reduce body mass index (BMI) and increase confidence in maintaining physical activity among students in universities in Jordan.

Who can participate?
University students in Jordan who are physically able to do moderate exercise

What does the study involve?
The participants will be allocated to one of two groups. One group will receive three educational lectures on the benefits of exercise, potential barriers to increasing physical activity and suggestions on how to change their behaviour to involve more physical activity. The other group will have a face-to-face consultation with individualised suggestions on how they could increase their physical activity. They will also receive 12 calls and regular text messages to encourage them to move more and have access to a Facebook page with tips and motivational messages.
All participants will wear a pedometer for 6 months to count their daily steps. They will also have their blood pressure, height and weight measured before and after the 6-month intervention period, and will fill out questionnaires on their physical activity levels and confidence in exercising at these times.

What are the possible benefits and risks of participating?
Participants might benefit from the education and encouragement to increase their physical activity. There were no additional risks of participation.

Where is the study run from?
Philadelphia University (Jordan)

When is the study starting and how long is it expected to run for?
December 2015 to September 2016

Who is funding the study?
Philadelphia University (Jordan)

Who is the main contact?
Dr Eman Alsaleh, ealsaleh@philadelphia.edu.jo

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eman Alsaleh

ORCID ID

Contact details

Philadelphia University
Jerash Road
Amman
19392
Jordan
+962 64799000
ealsaleh@philadelphia.edu.jo

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

A randomised controlled trial investigating the efficacy of a behavioural-based web and phone intervention to increase physical activity among university students in Jordan

Acronym

Study hypothesis

A behavioural intervention that consists of multiple components such as goal-setting, self-monitoring and feedback in a combination of effective delivery systems based on mobile and Facebook motivates students to increase their physical activity levels.

Ethics approval

Approved November 2016, Ethical board at Philadelphia University (Deanship of Scientific Research and Graduate Studies, Jerash Rd, Amman 19392, Jordan; +962 6 4799 000 Ext. 2366 or 2376; kma@philadelphia.edu.jo), no reference number

Study design

Two-arm single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

A participant information sheet was given to the participants before the study period. This sheet is not available in web format.

Condition

Physical activity in university students

Intervention

The study is two-group single-centre randomised controlled trial (n=150) in which a behavioural intervention was compared with usual care in increasing physical activity levels among healthy students in one Jordanian University. The participants were randomly allocated to the two groups (the control and intervention group) by opening opaque sealed sequence envelopes according to the participant’s numbers, which contained the name of the group.

The intervention consisted of delivering behavioural strategies by a single face-to-face individualised consultation with the researcher and six telephone call consultations (one call each month) supplemented by motivational SMS text messages reminders (one SMS weekly). The tailored consultation aimed to help participants to integrate moderate physical activity into their daily routine by performing brisk walking of 30 min daily for a minimum of 5 days per week or at least 10,000 steps per day using a bracelet pedometer to count their steps. In addition, the participants were contacted by a Facebook page (Let's walk) that aimed to deliver a motivational tips and advice to increase their physical activity levels.

The educational sessions were provided as three scheduled educational lectures about the benefits of physical activity, potential barriers to physical activity and using behavioral change strategies to increase physical activity levels. The duration of each educational lecture was 1 h. The lectures were given at the first month, the third month and the fifth month.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Steps per day measured using a bracelet pedometer worn by the participants around their wrists during the day. This bracelet pedometer measured individuals’ steps per day. The international recommendation for steps per day is 10,000-step/ day to achieve the international recommendations of 30 minutes of brisk walking per day.
2. Frequency of walking assessed using the International Physical Activity Questionnaire (IPAQ) at baseline and 6 months
3. Duration of walking assessed using the International Physical Activity Questionnaire (IPAQ) at baseline and 6 months
4. Frequency of walking assessed using the International Physical Activity Questionnaire (IPAQ) at baseline and 6 months

Secondary outcome measures

1. Blood pressure was measured by the researchers using automated electronic blood pressure monitor. To ensure consistency with this device, blood pressures of the participants was measured by the same BP monitor at baseline and at 6 months. Blood pressure was measured based on the criteria of measuring blood pressure determined by the American Heart Association, the British Hypertension Society and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
2. Body mass index calculated from height and weight. Body weight was measured with the same device at baseline and 6 months. Height was measured at baseline only.
3. Exercise self-efficacy assessed using the Exercise Self-Efficacy Scale (ESES) at baseline and 6 months. The scale was administered to identify the extent of the confidence of the subjects in performing the required levels of physical activity (regular moderate physical activity of 30 min 5 days a week) at a criterion level in specific situations by rating the level of their confidence.

Overall trial start date

01/12/2015

Overall trial end date

01/09/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Students of any subject at Philadelphia University
2. No medical condition that prevents them from doing moderate physical activity such as brisk walking

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

150 participants

Total final enrolment

146

Participant exclusion criteria

Illness or health conditions that prevent them from participating in physical activity

Recruitment start date

01/02/2016

Recruitment end date

01/03/2016

Locations

Countries of recruitment

Jordan

Trial participating centre

Philadelphia University
Jerash Rd
Amman
19392
Jordan

Sponsor information

Organisation

Philadelphia University

Sponsor details

Jerash Road
Amman
19392
Jordan
+962 6 4799 000 Ext. 2366 or 2376
kma@philadelphia.edu.jo

Sponsor type

University/education

Website

http://www.philadelphia.edu.jo/

Funders

Funder type

University/education

Funder name

Philadelphia University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study will be published in an international journal within 5 months.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from the author (Dr Eman Alsaleh, email address: ealsaleh@philadelphia.edu.jo). The data includes the intervention components and materials such as the consultations contents and the motivational tips and messages. These data can be obtained by sending a request by email after the results have been published in a journal.

Intention to publish date

01/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/01/2020: Trial's existence confirmed by Philadelphia University