Promoting a healthy lifestyle in adults with diabetes
| ISRCTN | ISRCTN71889430 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71889430 |
- Submission date
- 28/11/2020
- Registration date
- 01/12/2020
- Last edited
- 18/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The study aims to evaluate the effectiveness of a bespoke phone application, pedometers and phone consultations in promoting healthy lifestyle in adults with diabetes attending primary care facilities in Muscat, Oman.
Who can participate?
Adults aged 18-65 years of age, diagnosed with diabetes and overweight/obese
What does the study involve?
Participants will be randomly allocated to receive the intervention or usual care. Participants in the intervention group will receive phone personalised physical activity and diet consultations on four occasions (4, 12, 24 and 36 weeks), pedometers, and an interactive phone application (developed by the higher college of technology in Oman). The intervention will include self-monitoring and feedback on step counts and diet which will be provided within physical activity and diet consultations and discussed through communications in the interactive application.
What are the possible benefits and risks of participating?
No risks or side effects are anticipated from this study. However, participants will be advised to report any if it happens due to excessive physical activities which are rare.
Where is the study run from?
Health facilities in Muscat region (Oman)
When is the study starting and how long is it expected to run for?
January 2020 to May 2022
Who is funding the study?
The Research Council (Ministry of higher education) and Ministry of Health in Oman.
Who is the main contact?
Dr Thamra Al Ghafri, thamra74@yahoo.com
Dr Saud Al Harthi, smsbar07@gmail.com
Contact information
Public
PO Box 2723
Muscat
112
Oman
 ORCID ID |
0000-0002-4818-9565 |
|---|---|
| Phone | +968 (0)99279944 |
| thamra74@yahoo.com |
Public
PO Box 2723
Muscat
112
Oman
| Phone | +968 (0)99234543 |
|---|---|
| smsbar07@gmail.com |
Study information
| Study design | Cluster randomized control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | ISRCTN71889430_PIS.pdf |
| Scientific title | Behaviour change intervention to promote a healthy diet and physical activity in overweight/obese adults with diabetes attending health care facilities in Muscat: a cluster randomized control trial |
| Study objectives | A multi-component intervention using pedometer, phone consultation and a phone application is effective in promoting positive physical activity and diet control in obese adults with type 2 diabetes in primary diabetes care. |
| Ethics approval(s) | Approved 02/03/2020, National research and ethical review approval, Ministry of Health Oman (PO Box 393, Muscat, 100, Oman; +968 22357254; dg.plan16@gmail.com), ref: MOH/CSR/20/11516 |
| Health condition(s) or problem(s) studied | Prevention of multi-organ complications in obese adults with diabetes through healthy lifestyle (physical activity and diet) |
| Intervention | The study will be undertaken over a 1-year period in ten health facilities in Muscat. Participants in the intervention group will receive phone personalised physical activity and diet consultations on four occasions (4, 12, 24 and 36 weeks), pedometers, and an interactive phone application (developed by the higher college of technology in Oman). The intervention will include self-monitoring and feedback on step counts and diet which will be provided within physical activity and diet consultations and discussed through communications in the interactive application. The comparison group will receive usual care. These visits also allowed for data collection by clinic staff for research purposes in all health facilities at baseline, 3, 6 and 12 months. Randomisation: Random generated tables through SPSS v21 |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline and 1 year: 1. Physical activity behaviour (including sitting time) using the Global Physical activity questionnaire (GPAQ) 2. Diet control measured using a bespoke validated questionnaire |
| Secondary outcome measures | 1. Cardiovascular outcomes (BP and lipids) collected from the existing health information system at baseline and 12 months follow up 2. Anthropometric measures (weight, waist circumference and BMI) collected from the existing health information system at baseline and 12 months follow up 3. Metabolic outcomes (HBa1c) from the existing health information system at baseline and 12 months follow up |
| Overall study start date | 09/09/2019 |
| Completion date | 06/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Health facilities in Muscat region, Oman (n = 10), 750 participants |
| Key inclusion criteria | 1. Adults aged ≥18 - 65 years of age 2. Diagnosed with diabetes and overweight/obese 3. Attending (registered)health facilities for at least 6 months 4. Hba1c >7% (≥ 48 mmol/mol) according to Oman diabetes management guidelines 5. Assessed by project officer as having inactive behaviour 6. No contraindication to physical activity 7. Able to speak and read Arabic 8. Willing and able to provide written informed consent to the study 9. Can use phone applications |
| Key exclusion criteria | Patients with: 1. A history of myocardial infarction in the previous 6 months 2. A serum creatinine >140 mmol/l (from previous recorded readings in the electronic health information system) 3. Diabetic foot ulcers or at high risk of ulcer (severe peripheral neuropathy) 4. Repeated hypoglycaemia or severe hypoglycaemia in the previous 12 months 5. No internet access for the phone application 6. Physical activity > 150 minutes per week 7. Hba1c ≤7% |
| Date of first enrolment | 06/06/2021 |
| Date of final enrolment | 01/08/2021 |
Locations
Countries of recruitment
- Oman
Study participating centre
112
Oman
Sponsor information
Government
PO Box 3939
pc 100
Muscat
100
Oman
| Phone | +968 (0)24782120 |
|---|---|
| fatmaq.alhinai@moh.gov.om |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | It is expected to have at least six publications from this project. Proposed topics could be: 1. Study protocol 2. Study results (main results) 3. Description of sedentary behaviour in adults with diabetes 4. Behaviour change influencers 5. Results on the exit surveys 6. Factors influencing change in PA and sedentary behaviour |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 02/12/2020 | No | Yes | ||
| Protocol article | 10/08/2021 | 18/01/2024 | Yes | No |
Additional files
- ISRCTN71889430_PIS.pdf
- Uploaded 02/12/2020
Editorial Notes
19/01/2024: Publication reference added.
12/08/2021: Publication reference added.
02/06/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/01/2020 to 06/06/2021.
2. The recruitment end date has been changed from 06/06/2021 to 01/08/2021.
21/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/08/2021 to 06/06/2021.
2. The overall trial start date has been changed from 05/01/2020 to 09/09/2019.
3. The overall trial end date has been changed from 01/07/2022 to 06/06/2022.
14/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/06/2021 to 01/08/2021.
2. The overall trial end date has been changed from 01/05/2022 to 01/07/2022.
18/03/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/01/2020 to 01/06/2021.
2. The overall trial end date has been changed from 31/01/2021 to 01/05/2022 and the plain English summary has been updated accordingly.
3. The intention to publish date has been changed from 15/05/2021 to 01/01/2023.
02/12/2020: The participant information sheet has been uploaded as an additional file.
01/12/2020: Trial’s existence confirmed by Ministry of Health Oman.
