Diabetes Mellitus, Type 2SUNI-SEANCT05239572
Scaling Up NCD Interventions in South East Asia
A study testing screening, prevention and counselling in people with Diabetes Mellitus, Type 2 and Hypertension, run by University Medical Center Groningen at 1 site in Vietnam.
Trial summary
The SUNI-SEA study is an intervention study that measures effectiveness and cost-effectiveness of prevention and early diagnosis of diabetes and cardiovascular diseases in communities and primary healthcare (PHC) facilities in Indonesia, Myanmar and Vietnam. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases
- What is being tested?
- screening, prevention and counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,850 participants
- Where
- 1 siteVietnam
- Study dates
- 31 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults living in geographical area where research takes place
Who cannot join
- Persons who are not able to come to location of screening, due to illness or other chronic condition causing immobility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scaling Up Non-Communicable Diseases Interventions in South East Asia
The SUNI-SEA study is an intervention study that measures effectiveness and cost-effectiveness of prevention and early diagnosis of diabetes and cardiovascular diseases in communities and primary healthcare (PHC) facilities in Indonesia, Myanmar and Vietnam.
Read the detailed description
The study takes place in Vietnam and Indonesia in Intergenerational Self-Help Clubs (ISHGs), where community members assemble for activities concerning social, economical improvement and health and well-being. Volunteers in these ISHGs are trained in performing screening for diabetes and cardiovascular diseases and counselling participants concerning healthy living, or referral to primary healthcare facilities, if needed. At PHC level further diagnosis and if needed treatment is provided and referral back to ISHGs is done for lifestyle interventions.
In Indonesia screening takes place in the Posbindu programme, where trained volunteers (cadres) screen and counsel participants. If needed referral to Puskesmas (primary healthcare facilities is done, where further diagnosis and treatment takes place. Activities for health promotion and lifestyle interventions take place under supervision of the Posbindu programme.
In Myanmar and Indonesia individual monitoring and health education of participants is done through mobile applications.
Measuring of uptake, follow-up and adherence to interventions is done through routine data collection, through surveys, and through semi-structured interviews and focus group discussions.
- Being tested
- screening, prevention and counselling
- Keywords
- prevention, early diagnosis, lifestyle intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening, prevention and counsellingCombination product
Also called lifestyle coaching for persons with risk factors for NCDs, referral to primary healthcare facilities for further diagnosis and treatment, simple treatment of NCDs at primary healthcare level, Online monitoring and counselling for risk factors for NCDs
Screening in Intergenerational solidarity clubs in Myanmar and Vietnam and in Posbindu programme in Indonesia
| Study group | Role | What they receive |
|---|---|---|
| Screening and early detection of diabetes and cardiovascular diseases | Experimental | Screening for NCDs based on questionnaire concerning vital information, lifestyle, simple measures of length, bodyweight, BMI, blood pressure, application of FinRisk score and WHO risk score.
Health promotion and lifestyle counselling and referral to PHC facilities for further diagnosis and treatment. Receives: Combination Product: screening, prevention and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of NCD screening offered in communities
Number of adults eligible for NCD screening in communities who participate in screening
Measured: 18 months from offering screening options in communities until measuring uptake
Adherence to follow-up advice
Percentage of participants in screening who follow up on recommendations given during screening (referral, lifestyle change)
Measured: 12 months from counselling and advice to individual until measuring adherence to follow-up that has been recommended
Uptake of health education (health promotion, awareness of risk factors)
Percentage of adults above 21 years in communities participating in one or more health education sessions offered
Measured: 12 year between first health education session and measuring uptake (based on participants' lists)
Secondary outcomes (2)
Unit costs of screening, prevention and early diagnosis of NCDs per Quality Adjusted Life Year gained
Unit costs of NCD screening, prevention, early diagnosis intervention per Quality Adjusted Life Year gained
Measured: 18 months between starting calculation of costs of interventions and assessment of final assessment of benefits
Cost-effectiveness of NCD interventions
Comparison of costs and effects between intervention and business as usual, using diff in diff method
Measured: 18 months between baseline survey and endline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start31 Mar 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In Vietnam members from 60 Intergenerational Self Help Clubs have been screened for diabetes and cardiovascular diseases. (total 5,000 persons) In Myanmar members from 15 Intergenerational Solidarity Groups have undergone screening for diabetes and cardiovascular diseases using an internet application. (total 1850 persons) In Indonesia, visitors of 20 Posbindu programmes were offered screened for diabetes and hypertension in Central and East Java (10,000 persons)
- Masking
- None (open label)
- Enrolment
- 16,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen, University of Passau, Universitas Sebelas Maret, Health Strategy and Policy Institute, Trnavska Universita v Trnava, HelpAge International, Thai Nguyễn University of Medicine and Pharmacy
- Responsible party
- Sponsor
- Investigators
- Maarten Postma, PhD, Principal investigator, University Medical Center GroningenRobert Lensink, PhD, Principal investigator, University of GroningenAri Probandari, PhD, Principal investigator, University Sebelas MaretGiang Nguyen Hoang, MPH, Principal investigator, Health Strategy and Policy InstituteAnil Kumar Indira Krishna, PhD, Principal investigator, HelpAge InternationalMichael Grimm, PhD, Principal investigator, University of Passau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239572
- Sponsor's protocol ID
- 202100908
- Acronym
- SUNI-SEA
- Status last verified
- Oct 2023
- First submitted
- 3 Jan 2022
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following open research guidelines of European Union data will be shared about screening, follow-up and referral. Data collected in cos-effectiveness analysis will be shared
Publications
Hanifa RS, Rokhman MR, Fritz M, Widyaningsih V, Febrinasari RP, Koot JAR, Postma MJ, van der Schans J. Cost-effectiveness of community-based type 2 diabetes prevention and control in Indonesia: a health economics modelling study. BMJ Public Health. 2025 Oct 7;3(2):e002161. doi: 10.1136/bmjph-2024-002161. eCollection 2025.
PubMed 41069974Fritz M, Grimm M, My Hanh HT, Koot JAR, Nguyen GH, Nguyen TP, Probandari A, Widyaningsih V, Lensink R. Effectiveness of community-based diabetes and hypertension prevention and management programmes in Indonesia and Viet Nam: a quasi-experimental study. BMJ Glob Health. 2024 May 22;9(5):e015053. doi: 10.1136/bmjgh-2024-015053.
PubMed 38777393
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Up Non-Communicable Diseases Interventions in South East Asia
- ClinicalTrials.gov ID
- NCT05239572
- Acronym / sponsor ID
- SUNI-SEA / 202100908
- Keywords
- prevention, early diagnosis, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,850 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Groningen, University of Passau, Universitas Sebelas Maret, Health Strategy and Policy Institute, Trnavska Universita v Trnava, HelpAge International, Thai Nguyễn University of Medicine and Pharmacy
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SUNI-SEA study is an intervention study that measures effectiveness and cost-effectiveness of prevention and early diagnosis of diabetes and cardiovascular diseases in communities and primary healthcare (PHC) facilities in Indonesia, Myanmar and Vietnam.
Detailed description
The study takes place in Vietnam and Indonesia in Intergenerational Self-Help Clubs (ISHGs), where community members assemble for activities concerning social, economical improvement and health and well-being. Volunteers in these ISHGs are trained in performing screening for diabetes and cardiovascular diseases and counselling participants concerning healthy living, or referral to primary healthcare facilities, if needed. At PHC level further diagnosis and if needed treatment is provided and referral back to ISHGs is done for lifestyle interventions.
In Indonesia screening takes place in the Posbindu programme, where trained volunteers (cadres) screen and counsel participants. If needed referral to Puskesmas (primary healthcare facilities is done, where further diagnosis and treatment takes place. Activities for health promotion and lifestyle interventions take place under supervision of the Posbindu programme.
In Myanmar and Indonesia individual monitoring and health education of participants is done through mobile applications.
Measuring of uptake, follow-up and adherence to interventions is done through routine data collection, through surveys, and through semi-structured interviews and focus group discussions.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In Vietnam members from 60 Intergenerational Self Help Clubs have been screened for diabetes and cardiovascular diseases. (total 5,000 persons) In Myanmar members from 15 Intergenerational Solidarity Groups have undergone screening for diabetes and cardiovascular diseases using an internet application. (total 1850 persons) In Indonesia, visitors of 20 Posbindu programmes were offered screened for diabetes and hypertension in Central and East Java (10,000 persons)
| Arm | Type | Receives |
|---|---|---|
| Screening and early detection of diabetes and cardiovascular diseases | Experimental | Combination Product: screening, prevention and counsellingScreening for NCDs based on questionnaire concerning vital information, lifestyle, simple measures of length, bodyweight, BMI, blood pressure, application of FinRisk score and WHO risk score. Health promotion and lifestyle counselling and referral to PHC facilities for further diagnosis and treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults living in geographical area where research takes place
Key exclusion criteria (1 listed)
- Persons who are not able to come to location of screening, due to illness or other chronic condition causing immobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening, prevention and counsellingAlso: lifestyle coaching for persons with risk factors for NCDs, referral to primary healthcare facilities for further diagnosis and treatment, simple treatment of NCDs at primary healthcare level, Online monitoring and counselling for risk factors for NCDsScreening in Intergenerational solidarity clubs in Myanmar and Vietnam and in Posbindu programme in Indonesia | Combination product | Screening and early detection of diabetes and cardiovascular diseases |
Primary outcome
Uptake of NCD screening offered in communities
Time frame: 18 months from offering screening options in communities until measuring uptake
Number of adults eligible for NCD screening in communities who participate in screening
Adherence to follow-up advice
Time frame: 12 months from counselling and advice to individual until measuring adherence to follow-up that has been recommended
Percentage of participants in screening who follow up on recommendations given during screening (referral, lifestyle change)
Uptake of health education (health promotion, awareness of risk factors)
Time frame: 12 year between first health education session and measuring uptake (based on participants' lists)
Percentage of adults above 21 years in communities participating in one or more health education sessions offered
2 secondary outcomes
Unit costs of screening, prevention and early diagnosis of NCDs per Quality Adjusted Life Year gained
Time frame: 18 months between starting calculation of costs of interventions and assessment of final assessment of benefits
Cost-effectiveness of NCD interventions
Time frame: 18 months between baseline survey and endline survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 41069974Hanifa RS, Rokhman MR, Fritz M, Widyaningsih V, Febrinasari RP, Koot JAR, Postma MJ, van der Schans J. Cost-effectiveness of community-based type 2 diabetes prevention and control in Indonesia: a health economics modelling study. BMJ Public Health. 2025 Oct 7;3(2):e002161. doi: 10.1136/bmjph-2024-002161. eCollection 2025.
- Derived from this study: PubMed 38777393Fritz M, Grimm M, My Hanh HT, Koot JAR, Nguyen GH, Nguyen TP, Probandari A, Widyaningsih V, Lensink R. Effectiveness of community-based diabetes and hypertension prevention and management programmes in Indonesia and Viet Nam: a quasi-experimental study. BMJ Glob Health. 2024 May 22;9(5):e015053. doi: 10.1136/bmjgh-2024-015053.
- Individual participant dataSharing planned: Yes. Following open research guidelines of European Union data will be shared about screening, follow-up and referral. Data collected in cos-effectiveness analysis will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Postma, PhD principal investigator
University Medical Center Groningen
Robert Lensink, PhD principal investigator
University of Groningen
Ari Probandari, PhD principal investigator
University Sebelas Maret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening, prevention and counselling in people with Diabetes Mellitus, Type 2 and Hypertension, run by University Medical Center Groningen at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of NCD screening offered in communities (time frame: 18 months from offering screening options in communities until measuring uptake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05239572, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.