Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/01/2019
Date assigned
15/01/2019
Last edited
01/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Previous studies have shown that physical activity does not improve the glycemic (blood sugar) control of type 1 diabetes mellitus (T1DM) patients in 12 weeks. The aim of this study is to identify the effects of football (soccer) combined with a diet regimen on the glycemic control, health-related fitness, and health-related quality of life of boys with T1DM.

Who can participate?
Patients aged 13-18 who have had diabetes for more than a year, who do not have a disease that will hinder their participation in the study, and who can come to the study location

What does the study involve?
Participants are randomly allocated into four groups: football with diet, football only, diet only, and the control group. The football groups participate in 1 hour 30 minutes of football practice, twice a week for 12 weeks. The diet groups are provided with diet recommendations. The control group receive no interventions (usual care only). Body mass index (BMI), cardiorespiratory fitness, muscular fitness, resting heart rate, blood pressure, blood lipids, fasting blood glucose, glycated hemoglobin (HbA1c), and health-related quality of life are measured at the start of the study and after the program.

What are the possible benefits and risks of participating?
Benefits include an improvement in glycemic control after 12 weeks, blood lipids, blood pressure, health-related fitness, and health-related quality of life. The risk involved is that the participants in the football groups may experience low blood sugar levels while sleeping.

Where is the study run from?
The football program will take place at King Fahd University of Petroleum & Minerals. The patients in the diet group follow their regimen from their homes.

When is the study starting and how long is it expected to run for?
July 2016 to April 2019

Who is funding the study?
King Fahd University of Petroleum & Minerals (Saudi Arabia)

Who is the main contact?
Dr Mohammed Hamdan Hashem Mohammed

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohammed Hamdan Hashem Mohammed

ORCID ID

http://orcid.org/0000-0002-7193-2185

Contact details

PO Box 1366
King Fahd University of Petroleum & Minerals
Dhahran
31261
Saudi Arabia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IN171042

Study information

Scientific title

Effects of 12 weeks football with a diet regimen on glycemic control, selected health-related fitness parameters, and health-related quality of life of patients with type 1 diabetes: a randomized controlled trial

Acronym

Study hypothesis

Football combined with a diet regimen is the most suitable method for good glycemic control after 12 weeks for patients with type 1 diabetes when compared to football or diet alone.

Ethics approval

Ethics committee: Deanship of Scientific Research, King Fahd University of Petroleum & Minerals, PO Box 5083, Dhahran - 31261, Tel: +966138603200, Email: src@kfupm.edu.sa, 15/04/2018, ref: IN171042

Study design

Single-centre interventional randomised statistician-masked trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Type 1 diabetes mellitus

Intervention

Allocation: Simple randomization. The lab technicians and statistician will be blinded to group assignment.

Group 1: Football and diet regimen
Group 2: Football only
Group 3: Diet regimen only
Group 4: Regular care

Each football session will last 1 hour 30 minutes twice times a week for 12 weeks.

Expert dietitians will be consulted to provide a diet regimen for the intervention groups. The regimen will provide the necessary calories to reach and maintain the ideal body weight of the patients. The regimen will consider the cultural setting, food preferences, the weight of the patients, and their exercise and insulin dosage. The patients will be instructed to eat a fixed amount of calories daily for 12 weeks. A nutritionist specialized for patients with diabetes will provide information and training to the patients and their parents on how they should consume the amount of calories they need and how they record what they have eaten. The patients will submit weekly what they have consumed to the dietitians in order to check if they followed their recommendations.

The control group will receive no intervention (usual care only).

Body mass, body mass index (BMI), cardiorespiratory fitness, muscular fitness, resting heart rate, blood pressure, blood lipids, fasting blood glucose, HbA1c, and HRQoL will be measured at baseline and after the program. The HRQoL will be determined using The Pediatric Quality of Life Inventory (PedsQL™) with Diabetes Module 3.0. The primary outcome will be assessing glycemic control through changes in HbA1c after 12 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Glycemic control assessed through changes in glycated hemoglobin (HbA1c) at baseline and 12 weeks

Secondary outcome measures

Measured at baseline and 12 weeks:
1. Blood lipids and blood glucose measured by a lab test
2. Body mass index: mass and height measured with a mass scale and stadiometer, respectively
3. Cardiovascular fitness measured using the FitKids Treadmill Test
4. Muscular strength measured using standing long jump
5. Health-related quality of life measured using Arabic version of the PedsQL™ with the Diabetes Module 3.0

Overall trial start date

01/07/2016

Overall trial end date

15/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 12-18 years
2. Male
3. Diagnosed for diabetes for more than one year.
4. Should not have any medical condition that will hinder their participation in the study

Participant type

Patient

Age group

Child

Gender

Male

Target number of participants

40

Participant exclusion criteria

1. Has any medical condition that will hinder their participation in the study
2. Was diagnosed with diabetes less than a year ago
3. Those who cannot come to the study location

Recruitment start date

16/01/2019

Recruitment end date

17/01/2019

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

King Fahd University of Petroleum & Minerals
Dhahran
31261
Saudi Arabia

Sponsor information

Organisation

King Fahd University of Petroleum & Minerals

Sponsor details

Deanship of Scientific Research
Dhahran
31261
Saudi Arabia

Sponsor type

University/education

Website

http://www.kfupm.edu.sa/deanships/dsr/en/Pages/default.aspx

Funders

Funder type

University/education

Funder name

King Fahd University of Petroleum and Minerals

Alternative name(s)

KFUPM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Saudi Arabia

Results and Publications

Publication and dissemination plan

Additional documents (such as study protocol, statistical analysis plan, other) will be available upon request. Planned publication of the study results in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Mohammed Hamdan Hashem Mohammed. The data will be available after the first paper is published. The names of the participants shall be removed in order to hide their identities.

Intention to publish date

01/05/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/02/2019: The recruitment start date was changed from 15/04/2018 to 16/01/2019.