Determining the effects of football with a diet regimen on patients with type 1 diabetes
| ISRCTN | ISRCTN15906914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15906914 |
| Secondary identifying numbers | IN171042 |
- Submission date
- 07/01/2019
- Registration date
- 15/01/2019
- Last edited
- 14/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
PO Box 1366, King Fahd University of Petroleum & Minerals
Dhahran
31261
Saudi Arabia
 ORCID ID |
0000-0002-7193-2185 |
|---|
Study information
| Study design | Single-centre interventional randomised statistician-masked trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2016 |
| Completion date | 15/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Male |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/01/2019 |
| Date of final enrolment | 17/01/2019 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
31261
Saudi Arabia
Sponsor information
University/education
Deanship of Scientific Research
Dhahran
31261
Saudi Arabia
| Website | http://www.kfupm.edu.sa/deanships/dsr/en/Pages/default.aspx |
|---|---|
"ROR" |
https://ror.org/03yez3163 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- جامعة الملك فهد للبترول والمعادن, King Fahd University of Petroleum & Minerals, KFUPM
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 01/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/03/2021 | 14/09/2023 | Yes | No |
Editorial Notes
14/09/2023: Publication reference added.
01/02/2019: The recruitment start date was changed from 15/04/2018 to 16/01/2019.
