Religious leaders and diabetes prevention in Bangladesh
| ISRCTN | ISRCTN91564707 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91564707 |
| Secondary identifying numbers | BADAS-ERC/EC 122100330 |
- Submission date
- 24/04/2022
- Registration date
- 08/05/2022
- Last edited
- 09/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high.
Type 2 diabetes (T2DM) and related non-communicable diseases (NCDs) are common among the adult population in Bangladesh, which can be prevented through lifestyle modification. Evidence shows that culturally sensitive and behaviorally oriented faith-based intervention by religious leaders affects the prevention of T2DM and related NCDs.
Aim: To assess the outcome of faith-based intervention for the prevention of T2DM in high-risk subjects in Bangladesh.
Who can participate?
All individuals aged 25 years or older with diabetes risk score 9 or above and diagnosed with prediabetes (IFG/IGT) as per WHO recommended diagnostic value, permanent residents and willing to participate and available for 12 months of study.
What does the study involve?
Over the course of 12 months, this study will involve counseling, biophysical measurement, and laboratory investigations related to the study outcomes. In the intervention group, participants will visit twelve times (one each month) for counseling with religious leaders. They will discuss healthy lifestyles based on the religious sermon (khutbah) that benefits T2DM prevention. In addition, they will have three appointments (at the time of registration, 4 months, and 12 months) for structured healthy lifestyle education (including diet and physical activity) effective for T2DM prevention, biophysical measurement, and laboratory investigations with researchers from the Centre for Global Health Research of the Diabetic Association of Bangladesh. They will complete a questionnaire on changes in major nutritional and exercise habits and also the changes in Knowledge, Attitude, and Practice (KAP). All these appointments will be face-to-face. The subjects in the control group will be informed about a healthy lifestyle based on the religious sermon (khutbah). After the inclusion and collection of baseline data, they will visit the study site at 4 months and 12 months for the collection of anthropometric, clinical, and laboratory investigations. They will also complete a questionnaire on changes in major nutritional and exercise habits and also the changes in KAP.
What are the possible benefits and risks of participating?
This proposed study will fill up the gap in our existing knowledge by testing the effectiveness of faith-based intervention by religious leaders for the prevention of T2DM and related NCDs. No risk will be involved in this study.
Where is the study run from?
Centre for Global Health Research, Diabetic Association of Bangladesh
When is the study starting and how long is it expected to run for?
April 2022 to April 2023
Who is funding the study?
Non-Communicable Disease Control Program of Directorate General of Health Services, Ministry of Health and Family Welfare, Government of the People's Republic of Bangladesh.
Who is the main contact?
Dr Bishwajit Bhowmik, doctorbiplob@gmail.com
Contact information
Scientific
122, Kazi Nazrul Islam Avenue Shahbag
Dhaka
1000
Bangladesh
 ORCID ID |
0000-0003-1114-5873 |
|---|---|
| Phone | +880 1819287912 |
| doctorbiplob@gmail.com |
Study information
| Study design | Multicenter Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | 41624 PIS.pdf |
| Scientific title | Prevention of diabetes and related NCDs through religious leaders |
| Study acronym | DPRL |
| Study hypothesis | Faith-based intervention by religious leaders can affect the prevention of T2DM and related NCD risk factors. |
| Ethics approval(s) | Approved 19/04/2022, The Ethical Review Committee (ERC) of the Diabetic Association of Bangladesh (BADAS, 122 Kazi Nazrul Islam Avenue, Shahbag, Dhaka-1000, Bangladesh; +880-2-9661551; ERC@dab-bd.org), ref: BADAS-ERC/EC 122100330 |
| Condition | Prevention of diabetes |
| Intervention | Participants will be allocated at random in a 1:1 ratio. Intervention arm: provide healthy lifestyle information through religious sermon (khutbah) plus person-specific dietary and physical activity advice; Control arm: only provide healthy lifestyle information through religious sermon (khutbah) Follow up is for 12 months |
| Intervention type | Behavioural |
| Primary outcome measure | Rate of conversion from prediabetes to T2DM using blood glucose (both fasting and 2 hours after 75-gram blood glucose drink) among the study population at 4 months and 12 months |
| Secondary outcome measures | 1. Rate of T2DM between intervention and control group using blood glucose at 4 months and 12 months 2. Rate of cardiometabolic parameters including obesity (general and abdominal) by measuring anthropometric parameters, HTN by measuring blood pressure, and dyslipidemia by measuring fasting lipid profile between intervention and control group at 4 months and 12 months 3. Changes in physical activity, and dietary habits between intervention and control group using face-to-face interview (control group) and both face to face interview and guidebook at 4 months and 12 months 4. Level of changes in knowledge, attitude, and practice about T2DM and related cardiometabolic parameters among the study participants using the questionnaire at 4 months and 12 months |
| Overall study start date | 19/04/2022 |
| Overall study end date | 06/04/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 824 (intervention arm:412 & control arm: 412); equal number in all 8 centers. |
| Participant inclusion criteria | 1. All individuals aged ≥25 years with diabetes risk score ≥9 and diagnosed with prediabetes (IFG/IGT) as per WHO recommended diagnostic value. 2. Both genders 3. Permanent residents 4. Willing to participate and available for 12 months of study |
| Participant exclusion criteria | 1. Pregnant women or planned pregnancy and lactating mothers 2. Known case of T2DM 3. Individuals diagnosed with acute physical or mental illness at the time of screening |
| Recruitment start date | 07/05/2022 |
| Recruitment end date | 07/06/2022 |
Locations
Countries of recruitment
- Bangladesh
Study participating centre
Dhaka
1000
Bangladesh
Sponsor information
Government
Non-Communicable Disease Control Program of Directorate General of Health Services
Government of the People's Republic of Bangladesh
Mohakhali
Dhaka
1212
Bangladesh
| Phone | +880 222229207 |
|---|---|
| ncdc@ld.dghs.gov.bd | |
| Website | http://www.mohfw.gov.bd/ |
"ROR" |
https://ror.org/05256fm24 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request doctorbiplob@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 04/05/2022 | No | No | ||
| Other files | 04/05/2022 | No | Yes | ||
| Participant information sheet | 04/05/2022 | No | Yes | ||
| Protocol file | 12/04/2022 | 04/05/2022 | No | No |
Additional files
Editorial Notes
09/05/2022: Internal review.
04/05/2022: Trial's existence confirmed by Diabetic Association of Bangladesh
