HypertensionECoPHNCT07012096
Efficacy of Counselling for the Prevention of Hypertension (ECoPH)
A study testing counseling, leaflet and mhealth education for hypertension and Leaflets and mhealth education in people with Hypertension and Cardiovascular Diseases, run by Bangladesh University of Health Sciences at 1 site in Bangladesh.
Trial summary
This study aims to evaluate the effectiveness of counseling interventions in promoting positive changes in hypertension markers among adult slum dwellers. The intervention is designed to address modifiable risk factors, such as physical inactivity, obesity, unhealthy dietary practices, tobacco and harmful uses of… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- counseling, leaflet and mhealth education for hypertension and Leaflets and mhealth education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,700 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Oct 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: People who are not diagnosed as hypertensive patients are healthy and have no history of diseases and stay in the slum for at least one year.
Exclusion Criteria: People who have the following condition will be excluded:
- kidney disease
- psychiatric illness
- including depression
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Counselling for the Prevention of Hypertension Among Slum Dwellers in Dhaka City, Bangladesh
This study aims to evaluate the effectiveness of counseling interventions in promoting positive changes in hypertension markers among adult slum dwellers. The intervention is designed to address modifiable risk factors, such as physical inactivity, obesity, unhealthy dietary practices, tobacco and harmful uses of alcohol within a resource-limited community setting. The main question it aims to answer is:
- Is counseling a more effective intervention for the prevention of hypertension among adult slum dwellers in Dhaka city compared to other interventions?
Read more
Participants will:
- provide data related to tobacco use, physical activity, and dietary intake.
- provide a sample for blood pressure measurements. Will receive the WHO Brief Counselling intervention through 20 personalised sessions (each lasting approximately 20 minutes), focusing on lifestyle modifications, including physical activity promotion, balanced nutrition, and hypertension awareness.
Read the detailed description
This study aims to provide valuable insights into the effectiveness of counseling interventions in improving hypertension-related health outcomes among vulnerable urban populations. By focusing on modifiable risk factors, such as physical activity, dietary behavior, and tobacco use, the study will assess the potential of personalized counseling to reduce obesity, improve lipid profiles, and lower blood pressure. The intervention group will receive leaflet and counseling; and the control group will receive a leaflet only. After randomization, we will perform a baseline assessment. The participants will be allocated using stratified randomization. Allocation coverup will be ensured by performing allocation after completing all baseline assessments. A researcher who will not directly be involved with study delivery will allocate participants in a 1:1 ratio, generating a random sequence.
For both the primary and secondary outcomes, an intent-to-treat (ITT) design will be employed to ensure the robustness of the findings by including all participants, regardless of whether they complete the study or drop out. To address the potential impact of missing data due to dropout, participants will still be invited back for final assessment evaluations, minimizing bias in outcome measurement.
Through rigorous monitoring of primary and secondary outcomes in a double-blinded randomized controlled trial, the findings are expected to contribute to evidence-based public health interventions tailored for slum communities in Dhaka. These insights will guide future programs aimed at reducing the burden of hypertension and associated cardiovascular risks. The study will also highlight the importance of community-level preventive strategies in addressing chronic diseases where access to healthcare is limited. Ultimately, the research can inform scalable public health initiatives, advancing efforts toward equitable healthcare solutions in urban low-income settings
- Conditions
- Hypertension, Cardiovascular Diseases
- Being tested
- counseling, leaflet and mhealth education for hypertension, Leaflets and mhealth education, Dummy Placebo
- Keywords
- Hypertension, Cardiovascular diseases, counseling intervention, urban slums, randomized controlled trial, preventive healthcare, Dhaka, Good Clinical Practices
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling, leaflet and mhealth education for hypertensionBehavioural
Investigators will develop 6 leaflets and 24-SMSs containing messages on the burden of hypertension, consequences, and the benefits of preventing of hypertension, and the healthy practices for preventing hypertension, tobacco, physical inactivity, dietary salt intake, inadequate fruits and vegetables, overweight and obesity, and the use of trans fat. It will be written in plain and simple Bengali. Leaflets will be received by CG-1, CG-3, IG-1 and IG-3. 24-SMSs. Face-to-face counselling (approximately 20 min/session). A total of 20 sessions (1 cycle) will be provided. The session will be repeated if the cycle is over.
Leaflets and mhealth educationBehavioural
Participants will receive 6 leaflets containing messages on the burden of hypertension, consequences, and benefits of prevention of hypertension, and the healthy practices for preventing hypertension.
Participants will receive 24 SMSs containing the burden of hypertension, consequences, and benefits of prevention of hypertension, and the healthy practices for preventing hypertension.
And additionally receive a dummy counselling of 5 to 10 minutes informal discussion with the participants, which will not include any health messages that will be received by the participants of the intervention group.
Dummy PlaceboOther
Participants will only receive a dummy counselling of 5 to 10 minutes informal discussion with the participants, which will not include any health messages that will be received by the participants of the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Control group (CG) | Active comparator | CG-1: Leaflet + Dummy counselling CG-2: Mobile SMS + Dummy counselling CG-3: Leaflet + Mobile SMS + Dummy counselling Receives: Behavioral: Leaflets and mhealth education |
| Placebo | Placebo comparator | CG-4: No intervention + Dummy counselling. Receives: Other: Dummy Placebo |
| Intervention group (IG) | Experimental | IG-1: Leaflet + Counselling (WHO Brief interventions) IG-2: Mobile SMS + Counselling (WHO Brief interventions) IG-3: Leaflet + Mobile SMS + Counselling (WHO Brief interventions) IG-4: Counselling (WHO Brief interventions) Receives: Behavioral: counseling, leaflet and mhealth education for hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI classification (kg/m²)
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). The participants will be considered as obese and over-weight when BMI ≥ 30kg/m2 and 25-29.9 kg/m2, respectively
Measured: From enrollment until 18 months
Waist circumference (cm)
Central obesity was categorized according to the cut-off value specified by the international Diabetes Federation--- waist circumference 90 cm for men and 80 cm for women or waist-hip ratio>0.90 for men and >0.85 for women.
Measured: From enrollment until 18 months
Waist-to-hip ratio
Waist-to-hip ratio will be calculated as the ratio of waist circumference to hip circumference. Central obesity will be defined as a ratio >0.90 in men and >0.85 in women.
Measured: From enrollment until 18 months
Tobacco use in the past 30 days
Those who have the past 30 days history of smoking or use of smokeless tobacco will be considered as a current tobacco user.
Measured: From enrollment until 18 months
Physical activity level (MET-minutes/week)
As per the WHO STEPS protocol, we were converted all work-related physical activities in metabolic equivalent of task in minutes per day (MET-minute) as follows:
1 minute in sedentary position = 1 MET-minute
1 minute in a moderate physical activity = 4 MET-minutes
1 minute in a vigorous physical activity = 8 MET-minutes
All MET-minutes were then added together to get the cumulative MET-minutes. As per the cumulative MET-minutes, participants were categorized as less, moderately, and highly active:
- 600 MET-minutes per week = less active
- 600-3000 MET-minutes per week = moderately active ≥ 3000 MET-minutes per week = highly active
The rest of the respondents, those didn't not meet even moderate activities, they were categorized as low activity
Measured: From enrollment until 18 months
Inadequate fruit and/or vegetables intake (servings)
WHO recommendation of fruit and/or vegetable intake <5 servings per day was considered as an inadequate intake. Participants will be asked about the number of days they used to eat fruit and vegetables in a week and the number of servings on those days they eat these. One standard serving size equal to 80 grams.
Measured: From enrollment until 18 months
Dietary salt intake
The added salt consumption will be defined as taking dietary salt during eating a meal.
Measured: From enrollment until 18 months
Secondary outcomes (10)
Systolic Blood pressure (mmHg)
The blood pressure of the respondents will be measured following WHO guideline for blood pressure measurement using WHO-certified automated blood pressure monitor namely OMRON model HEM-7121 made in Japan. Hypertension will be defined as SBP ≥140 mmHg or if the participant is on antihypertensive treatment.
Measured: From enrollment until 18 months
Diastolic blood pressure (mmHg)
The participants will be considered hypertensive when the systolic blood pressure reading was ≥140 mmHg and/or the diastolic blood pressure reading was ≥ 90 mmHg or known case hypertensive or on antihypertensive medication. Raised blood pressure means SBP: ≥ 120 mmHg and /or DBP: ≥ 80 mmHg
Measured: From enrollment until 18 months
Heart rate (beats per minute)
Heart rate refers to the number of times the heart beats per minute (bpm). In this study, heart rate will be measured using a validated automated device (OMRON model HEM-7121) following the standard protocols recommended by the World Health Organization. Participants will be instructed to rest for at least five minutes before the measurement to ensure accuracy. Heart rate readings will be taken at baseline and follow-up intervals to track any significant changes over time, with abnormal heart rates defined as below 60 bpm (bradycardia) or above 100 bpm (tachycardia) in accordance with clinical guidelines.
Measured: From enrollment until 18 months
Lipid profile (mg/dL)
Serum total cholesterol, triglycerides and HDL-cholesterol will be measured by end-point method using Backman Coulter AU-480 automated Biochemistry analyzer. Serum LDL-cholesterol will be calculated using Friedewald formula.
Dyslipidemia was defined as Total Cholesterol ≥ 200 mg/dl, or Triglycerides ≥150 mg/dl, or Low-density lipoprotein cholesterol (LDL-C) ≥ 130 mg/dl, or HDL-C < 40 mg/dl (for men) and High-density lipoprotein cholesterol (HDL-C) < 50 (for women)
Measured: From enrollment until 18 months
Fasting blood glucose (mg/dL)
Fasting blood sugar levels will be measured from venous samples following an 8-hour fast using the Turbidimetric Immunoinhibition methods using Backman Coulter AU-480.
Measured: From enrollment until 18 months
Diagnosis of Type 2 Diabetes Mellitus
Type 2 diabetes mellitus will be diagnosed if fasting blood glucose is ≥126 mg/dL or if the participant is on antidiabetic medication, following WHO criteria.
Measured: From enrollment until 18 months
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
Hs-CRP will be measured using turbidimetric immunoassay methods with a Beckman Coulter AU-480 automated biochemistry analyzer. Blood samples will be collected from participants after fasting, and Hs-CRP levels will be expressed in milligrams per liter (mg/L). Following clinical standards, values below 1 mg/L indicate low cardiovascular risk, 1-3 mg/L represent moderate risk, and above 3 mg/L indicate high cardiovascular risk
Measured: From enrollment until 18 months
Urine creatinine test (mg/dL)
Following instruction on proper urine preservation, participants were given a 15-20 ml sterile labeled container to collect urine for urine specimens, which were to be stored overnight at room temperature before being collected the following morning. The creatinine level was estimated using the Jaffy method and the Backman Coulter AU-480 automated Biochemistry analyzer was used to measure serum creatinine.
Measured: From enrollment until 18 months
Urinary sodium (Na+) and potassium (K+) estimation (mmol/L)
In this investigation, we employed the Tanaka equation to estimate 24-hour urine Na+, K+, and Na+/K+ ratio. The equation used Japanese data items from the INTERSALT project, which was carried out using a highly standardized technique, to build this equation to estimate 24-hour urine Na+ and K+ excretion. By contrasting 24-hour urine samples with spot urine from the same participants, they were able to create this equation. Additional data utilized to create the equation included the respondents' age, sex, height, weight, and creatinine levels. This was then used to get the 24-hour sodium intake, which was then divided by 17.1 as a conversion factor to determine the predicted salt intake in grams. Using the Backman Coulter AU-480 automated biochemistry analyzer, the ISE method will be used to measure the amount of sodium (Na+) in the urine.
Measured: From enrollment until 18 months
10-year cardiovascular disease (CVD) risk prediction
CVD risk will be estimated using WHO/ISH risk prediction charts (version 2023), incorporating factors like age, sex, blood pressure, smoking status, diabetes, and total cholesterol. Risk will be categorized as very low risk <5%, low risk 5%-<10%, moderate risk 10%-<20%, high risk 20%-<30% and very high risk ≥30%
Measured: From enrollment until 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh University of Professionals
- Responsible party
- Principal investigator, Palash Chandra Banik, Bangladesh University of Health Sciences
- Investigators
- Palash C. Banik, MPhil in Noncommunicable disea, Principal investigator, Bangladesh University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012096
- Sponsor's protocol ID
- LS20221832
- Acronym
- ECoPH
- Status last verified
- Feb 2026
- First submitted
- 26 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Counselling for the Prevention of Hypertension Among Slum Dwellers in Dhaka City, Bangladesh
- ClinicalTrials.gov ID
- NCT07012096
- Acronym / sponsor ID
- ECoPH / LS20221832
- Conditions
- Hypertension, Cardiovascular Diseases
- Keywords
- Hypertension, Cardiovascular diseases, counseling intervention, urban slums, randomized controlled trial, preventive healthcare, Dhaka, Good Clinical Practices
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Bangladesh University of Health SciencesUniversity, hospital or other
- Collaborators
- Bangladesh University of Professionals
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 10 Jun 2025 (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.
This study aims to evaluate the effectiveness of counseling interventions in promoting positive changes in hypertension markers among adult slum dwellers. The intervention is designed to address modifiable risk factors, such as physical inactivity, obesity, unhealthy dietary practices, tobacco and harmful uses of alcohol within a resource-limited community setting. The main question it aims to answer is:
- Is counseling a more effective intervention for the prevention of hypertension among adult slum dwellers in Dhaka city compared to other interventions?
Participants will:
- provide data related to tobacco use, physical activity, and dietary intake.
- provide a sample for blood pressure measurements. Will receive the WHO Brief Counselling intervention through 20 personalised sessions (each lasting approximately 20 minutes), focusing on lifestyle modifications, including physical activity promotion, balanced nutrition, and hypertension awareness.
Detailed description
This study aims to provide valuable insights into the effectiveness of counseling interventions in improving hypertension-related health outcomes among vulnerable urban populations. By focusing on modifiable risk factors, such as physical activity, dietary behavior, and tobacco use, the study will assess the potential of personalized counseling to reduce obesity, improve lipid profiles, and lower blood pressure. The intervention group will receive leaflet and counseling; and the control group will receive a leaflet only. After randomization, we will perform a baseline assessment. The participants will be allocated using stratified randomization. Allocation coverup will be ensured by performing allocation after completing all baseline assessments. A researcher who will not directly be involved with study delivery will allocate participants in a 1:1 ratio, generating a random sequence.
For both the primary and secondary outcomes, an intent-to-treat (ITT) design will be employed to ensure the robustness of the findings by including all participants, regardless of whether they complete the study or drop out. To address the potential impact of missing data due to dropout, participants will still be invited back for final assessment evaluations, minimizing bias in outcome measurement.
Through rigorous monitoring of primary and secondary outcomes in a double-blinded randomized controlled trial, the findings are expected to contribute to evidence-based public health interventions tailored for slum communities in Dhaka. These insights will guide future programs aimed at reducing the burden of hypertension and associated cardiovascular risks. The study will also highlight the importance of community-level preventive strategies in addressing chronic diseases where access to healthcare is limited. Ultimately, the research can inform scalable public health initiatives, advancing efforts toward equitable healthcare solutions in urban low-income settings
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group (CG) | Active comparator | Behavioral: Leaflets and mhealth educationCG-1: Leaflet + Dummy counselling CG-2: Mobile SMS + Dummy counselling CG-3: Leaflet + Mobile SMS + Dummy counselling |
| Placebo | Placebo comparator | Other: Dummy PlaceboCG-4: No intervention + Dummy counselling. |
| Intervention group (IG) | Experimental | Behavioral: counseling, leaflet and mhealth education for hypertensionIG-1: Leaflet + Counselling (WHO Brief interventions) IG-2: Mobile SMS + Counselling (WHO Brief interventions) IG-3: Leaflet + Mobile SMS + Counselling (WHO Brief interventions) IG-4: Counselling (WHO Brief interventions) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| counseling, leaflet and mhealth education for hypertensionInvestigators will develop 6 leaflets and 24-SMSs containing messages on the burden of hypertension, consequences, and the benefits of preventing of hypertension, and the healthy practices for preventing hypertension, tobacco, physical inactivity, dietary salt intake, inadequate fruits and vegetables, overweight and obesity, and the use of trans fat. It will be written in plain and simple Bengali. Leaflets will be received by CG-1, CG-3, IG-1 and IG-3. 24-SMSs. Face-to-face counselling (approximately 20 min/session). A total of 20 sessions (1 cycle) will be provided. The session will be repeated if the cycle is over. | Behavioural | Intervention group (IG) |
| Leaflets and mhealth educationParticipants will receive 6 leaflets containing messages on the burden of hypertension, consequences, and benefits of prevention of hypertension, and the healthy practices for preventing hypertension. Participants will receive 24 SMSs containing the burden of hypertension, consequences, and benefits of prevention of hypertension, and the healthy practices for preventing hypertension. And additionally receive a dummy counselling of 5 to 10 minutes informal discussion with the participants, which will not include any health messages that will be received by the participants of the intervention group. | Behavioural | Control group (CG) |
| Dummy PlaceboParticipants will only receive a dummy counselling of 5 to 10 minutes informal discussion with the participants, which will not include any health messages that will be received by the participants of the intervention group. | Other | Placebo |
Primary outcome
BMI classification (kg/m²)
Time frame: From enrollment until 18 months
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). The participants will be considered as obese and over-weight when BMI ≥ 30kg/m2 and 25-29.9 kg/m2, respectively
Waist circumference (cm)
Time frame: From enrollment until 18 months
Central obesity was categorized according to the cut-off value specified by the international Diabetes Federation--- waist circumference 90 cm for men and 80 cm for women or waist-hip ratio>0.90 for men and >0.85 for women.
Waist-to-hip ratio
Time frame: From enrollment until 18 months
Waist-to-hip ratio will be calculated as the ratio of waist circumference to hip circumference. Central obesity will be defined as a ratio >0.90 in men and >0.85 in women.
Tobacco use in the past 30 days
Time frame: From enrollment until 18 months
Those who have the past 30 days history of smoking or use of smokeless tobacco will be considered as a current tobacco user.
Physical activity level (MET-minutes/week)
Time frame: From enrollment until 18 months
As per the WHO STEPS protocol, we were converted all work-related physical activities in metabolic equivalent of task in minutes per day (MET-minute) as follows: 1 minute in sedentary position = 1 MET-minute 1 minute in a moderate physical activity = 4 MET-minutes 1 minute in a vigorous physical activity = 8 MET-minutes All MET-minutes were then added together to get the cumulative MET-minutes. As per the cumulative MET-minutes, participants were categorized as less, moderately, and highly active: * 600 MET-minutes per week = less active * 600-3000 MET-minutes per week = moderately active ≥ 3000 MET-minutes per week = highly active The rest of the respondents, those didn't not meet even moderate activities, they were categorized as low activity
Inadequate fruit and/or vegetables intake (servings)
Time frame: From enrollment until 18 months
WHO recommendation of fruit and/or vegetable intake <5 servings per day was considered as an inadequate intake. Participants will be asked about the number of days they used to eat fruit and vegetables in a week and the number of servings on those days they eat these. One standard serving size equal to 80 grams.
Dietary salt intake
Time frame: From enrollment until 18 months
The added salt consumption will be defined as taking dietary salt during eating a meal.
10 secondary outcomes
Systolic Blood pressure (mmHg)
Time frame: From enrollment until 18 months
Diastolic blood pressure (mmHg)
Time frame: From enrollment until 18 months
Heart rate (beats per minute)
Time frame: From enrollment until 18 months
Lipid profile (mg/dL)
Time frame: From enrollment until 18 months
Fasting blood glucose (mg/dL)
Time frame: From enrollment until 18 months
Diagnosis of Type 2 Diabetes Mellitus
Time frame: From enrollment until 18 months
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
Time frame: From enrollment until 18 months
Urine creatinine test (mg/dL)
Time frame: From enrollment until 18 months
Urinary sodium (Na+) and potassium (K+) estimation (mmol/L)
Time frame: From enrollment until 18 months
10-year cardiovascular disease (CVD) risk prediction
Time frame: From enrollment until 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
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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.
Palash C. Banik, MPhil in Noncommunicable disea principal investigator
Bangladesh University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling, leaflet and mhealth education for hypertension and Leaflets and mhealth education in people with Hypertension and Cardiovascular Diseases, run by Bangladesh University of Health Sciences at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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 Bangladesh. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
BMI classification (kg/m²) (time frame: From enrollment until 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.