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
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