Non Communicable DiseasesNCT04827615
Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India
A study testing Ambuja Cement Foundation's Non Communicable Disease Program in people with Non Communicable Diseases and Blood Pressure, run by Harvard School of Public Health (HSPH) at 1 site in India.
Trial summary
This is an academic evaluation of a program being implemented by the Ambuja Cement Foundation (ACF). The aim of the evaluation is to determine the effect of the ACF noncommunicable disease (NCD) program on (1) fasting blood glucose (a biomarker of diabetes), (2) systolic blood pressure, (3) diastolic blood pressure… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Communicable Diseases, Blood Pressure, Behavior, Health
- What is being tested?
- Ambuja Cement Foundation's Non Communicable Disease Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,322 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jul 2019to 30 Sep 2024
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Reside in the study area (12 villages in Bathinda District of Punjab, India). "Residence" will be defined as sleeping in a house in that village on a typical weeknight.
- ≥30 years old. Age will be confirmed by directly viewing a government-issued document with the individual's date of birth.
- Willing to provide informed consent.
Who cannot join
- • Plan to move permanently out of the study area in the next 12 months.
- Pregnant (women via self-report).
- Persons who are bedridden or mentally challenged.
- Persons who speak a language other than Punjabi, Hindi, or English
Trial locations and contacts
1 site in 1 country.
About this study
This is an academic evaluation of a program being implemented by the Ambuja Cement Foundation (ACF). The aim of the evaluation is to determine the effect of the ACF noncommunicable disease (NCD) program on (1) fasting blood glucose (a biomarker of diabetes), (2) systolic blood pressure, (3) diastolic blood pressure, and (4) body weight.
ACF will be implementing a program on NCD management. Due to resource constraints, the program will be implemented stepwise (e.g. four villages in the first 6 months then an additional four villages added every 6 months over the next 12 months). In order to improve the interpretation of the evaluation data, the team will randomize the order in which the program is implemented in the 12 villages. The design is therefore a stepped wedge randomized cluster trial. This design is ideal for (1) minimizing the practical, logistical, and financial constraints associated with large-scale project implementation, (2) control for the effect of time, and (3) ensure that all villages in the project are eventually offered the intervention.
Read the detailed description
Evaluation visits will be conducted at the participant's home. At baseline, the ACF field team will first administer a screening questionnaire to all adults in the household to confirm eligibility. For those adults who meet all eligibility criteria, trained enumerators will (1) complete two brief surveys, (2) measure their waist circumference and body weight, and (3) measure their blood pressure using an automatic digital blood pressure machine. The surveys will cover demographics, family history of disease, tobacco and alcohol use, physical activity, and standard clinical symptoms. The field team will then schedule a follow-up visit within the next week to measure fasting blood glucose using a point-of-care device. For those adults who meet criteria for being high-risk for diabetes and hypertension (criteria defined further in the next section), trained enumerators will also administer an additional survey on this second day that covers dietary intake and clinical history including medication use.
For high-risk adults, after the baseline visit, three additional follow-up visits will be completed every 6 months for a total duration of 18 months. Each follow-up visit will include: two brief surveys covering the same content summarized above for baseline, as well as measurements of waist circumference, body weight, blood pressure, and fasting blood glucose. The visits will be scheduled such that participants are fasting on the day of the visit, thus allowing all visit activities to be completed in 1 day.
All surveys will be completed via interviews by trained field enumerators who will enter participant responses into password-protected tablets (Qualtrics offline mobile app).
The total population of these 12 villages is 60,701 according to the 2011 Census. All adults ≥30 years old meeting eligibility criteria will be enrolled, which is estimated to be ~40% of the total population or ~24,280 people. Based on ACF's current programming in 2 other villages in this district, it is expected that 40% of those screened (Group 1 participants) will be high-risk (Group 2 participants) or ~9,720 people (~810 per village).
For fasting blood glucose, a sample of 12 clusters in a complete stepped-wedge cluster-randomized design with 4 time periods (including the baseline), 3 steps, 4 clusters switching from control to treatment at each step, and an average of 500 participants per cluster with an average of 125 participants per cluster per time period (for a total sample size of 6000 subjects) achieves 90% power to detect a difference between means of 0.32 mmol/L (4% of anticipated mean baseline level). The test statistic used is the two-sided Wald Z-Test. The intra-class correlation coefficient (ICC) is 0.010, and the significance level of the test is 0.050. Given that near to 9000 participants are expected to be enrolled, the team is exceptionally well powered to detect significant effects in this evaluation even if there is loss to follow up.
- Conditions
- Non Communicable Diseases, Blood Pressure, Behavior, Health, Blood Glucose, High, Blood Glucose, Low, Diabetes Type 2
- Being tested
- Ambuja Cement Foundation's Non Communicable Disease Program
- Keywords
- Evaluation, Non Communicable Disease, Body weight, Diet
- Medical subject headings
- Noncommunicable Diseases, Health Behavior, Diabetes Mellitus, Type 2, Mental Disorders, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambuja Cement Foundation's Non Communicable Disease ProgramBehavioural
Government level: Strengthening linkages with Govt; Ensuring availability \& affordability of NCD diagnostics and treatment; Establishing a follow-up mechanism with patients to ensure continuity of care \& medication compliance
Provider level: Capacity building of frontline workers; Promotion of interface between community \& service provider
Community level: Screening of hypertension \& diabetes for all adults ≥30 years in the village in coordination with Govt under 'population based screening'; Create awareness of modifiable risk factors and lifestyle change among high-risk population; Community mobilization \& active participation in various health marker days; Formation of support groups, women's groups, self help groups, with involvement of people living with NCDs
Individual level: Behavior change communication with messages on NCD risk factors; Nutrition awareness on healthy and unhealthy food practices
| Study group | Role | What they receive |
|---|---|---|
| High Risk | Other | Group 2: Of all adults in (1), those at high risk of diabetes and hypertension, defined as having a score >4 based on the following criteria:
* Age 40-49 years (+1), age ≥50 years (+2)
* Used to smoke or use smokeless tobacco products or sometimes currently use (+1), currently use daily (+2)
* Currently consume alcohol daily (+1)
* Waist circumference 81-90 cm (women)/91-100 cm (men) (+1), >90 cm (women)/>100cm (men) (+2)
* Physical activity <150 minutes per week (+1)
* Parent and/or sibling with high blood pressure, diabetes, or heart disease (+2) Receives: Behavioral: Ambuja Cement Foundation's Non Communicable Disease Program |
| Eligible adults | Other | Group 1: All adults ≥30 years old living in the 12 target villages who meet eligibility criteria and provide informed consent Receives: Behavioral: Ambuja Cement Foundation's Non Communicable Disease Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Fasting blood glucose will be measured using a point-of-care device
Measured: Four measures over 12 months
Systolic and Diastolic blood pressure
Blood pressure will be measured using an automatic digital blood pressure machine
Measured: Four measures over 12 months
Body weight
Body weight will be measured using a weighing scale
Measured: Four measures over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start30 Jul 2019
- Primary completion30 Jan 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Communicable DiseasesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study design is stepped wedge randomized cluster trial (4 villages in the first 6 months; additional 4 villages added every 6 months over the next 12 months) - randomized implementation. Staff will visit 10 target villages to screen participants for high NCD risk using Community Based Assessment Checklist scoring. For adults meeting eligibility criteria, trained enumerators will (1) complete 2 brief surveys (2) measure waist circumference (3) measure blood pressure. Follow-up visits will be scheduled to measure fasting blood glucose. For adults who meet high-risk criteria for diabetes \& hypertension, an additional survey will be conducted on the 2nd day covering dietary intake \& clinical history. 3 additional follow-up visits will be completed every 6 months for 18 months. Each visit will include: 2 surveys like baseline, measurements of waist circumference, blood pressure, \& fasting blood glucose. All participants identified as high risk will be referred to a public hospital.
- Masking
- None (open label)
- Enrolment
- 11,322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Ambuja Cement Foundation
- Responsible party
- Principal investigator, Shilpa N Bhupathiraju, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827615
- Sponsor's protocol ID
- IRB19-1217
- Status last verified
- May 2024
- First submitted
- 30 Mar 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India
- ClinicalTrials.gov ID
- NCT04827615
- Acronym / sponsor ID
- IRB19-1217
- Conditions
- Non Communicable Diseases, Blood Pressure, Behavior, Health, Blood Glucose, High, Blood Glucose, Low, Diabetes Type 2
- Keywords
- Evaluation, Non Communicable Disease, Body weight, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,322 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Ambuja Cement Foundation
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Apr 2021 (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 is an academic evaluation of a program being implemented by the Ambuja Cement Foundation (ACF). The aim of the evaluation is to determine the effect of the ACF noncommunicable disease (NCD) program on (1) fasting blood glucose (a biomarker of diabetes), (2) systolic blood pressure, (3) diastolic blood pressure, and (4) body weight.
ACF will be implementing a program on NCD management. Due to resource constraints, the program will be implemented stepwise (e.g. four villages in the first 6 months then an additional four villages added every 6 months over the next 12 months). In order to improve the interpretation of the evaluation data, the team will randomize the order in which the program is implemented in the 12 villages. The design is therefore a stepped wedge randomized cluster trial. This design is ideal for (1) minimizing the practical, logistical, and financial constraints associated with large-scale project implementation, (2) control for the effect of time, and (3) ensure that all villages in the project are eventually offered the intervention.
Detailed description
Evaluation visits will be conducted at the participant's home. At baseline, the ACF field team will first administer a screening questionnaire to all adults in the household to confirm eligibility. For those adults who meet all eligibility criteria, trained enumerators will (1) complete two brief surveys, (2) measure their waist circumference and body weight, and (3) measure their blood pressure using an automatic digital blood pressure machine. The surveys will cover demographics, family history of disease, tobacco and alcohol use, physical activity, and standard clinical symptoms. The field team will then schedule a follow-up visit within the next week to measure fasting blood glucose using a point-of-care device. For those adults who meet criteria for being high-risk for diabetes and hypertension (criteria defined further in the next section), trained enumerators will also administer an additional survey on this second day that covers dietary intake and clinical history including medication use.
For high-risk adults, after the baseline visit, three additional follow-up visits will be completed every 6 months for a total duration of 18 months. Each follow-up visit will include: two brief surveys covering the same content summarized above for baseline, as well as measurements of waist circumference, body weight, blood pressure, and fasting blood glucose. The visits will be scheduled such that participants are fasting on the day of the visit, thus allowing all visit activities to be completed in 1 day.
All surveys will be completed via interviews by trained field enumerators who will enter participant responses into password-protected tablets (Qualtrics offline mobile app).
The total population of these 12 villages is 60,701 according to the 2011 Census. All adults ≥30 years old meeting eligibility criteria will be enrolled, which is estimated to be ~40% of the total population or ~24,280 people. Based on ACF's current programming in 2 other villages in this district, it is expected that 40% of those screened (Group 1 participants) will be high-risk (Group 2 participants) or ~9,720 people (~810 per village).
For fasting blood glucose, a sample of 12 clusters in a complete stepped-wedge cluster-randomized design with 4 time periods (including the baseline), 3 steps, 4 clusters switching from control to treatment at each step, and an average of 500 participants per cluster with an average of 125 participants per cluster per time period (for a total sample size of 6000 subjects) achieves 90% power to detect a difference between means of 0.32 mmol/L (4% of anticipated mean baseline level). The test statistic used is the two-sided Wald Z-Test. The intra-class correlation coefficient (ICC) is 0.010, and the significance level of the test is 0.050. Given that near to 9000 participants are expected to be enrolled, the team is exceptionally well powered to detect significant effects in this evaluation even if there is loss to follow up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is stepped wedge randomized cluster trial (4 villages in the first 6 months; additional 4 villages added every 6 months over the next 12 months) - randomized implementation. Staff will visit 10 target villages to screen participants for high NCD risk using Community Based Assessment Checklist scoring. For adults meeting eligibility criteria, trained enumerators will (1) complete 2 brief surveys (2) measure waist circumference (3) measure blood pressure. Follow-up visits will be scheduled to measure fasting blood glucose. For adults who meet high-risk criteria for diabetes \& hypertension, an additional survey will be conducted on the 2nd day covering dietary intake \& clinical history. 3 additional follow-up visits will be completed every 6 months for 18 months. Each visit will include: 2 surveys like baseline, measurements of waist circumference, blood pressure, \& fasting blood glucose. All participants identified as high risk will be referred to a public hospital.
| Arm | Type | Receives |
|---|---|---|
| High Risk | Other | Behavioral: Ambuja Cement Foundation's Non Communicable Disease ProgramGroup 2: Of all adults in (1), those at high risk of diabetes and hypertension, defined as having a score >4 based on the following criteria: * Age 40-49 years (+1), age ≥50 years (+2) * Used to smoke or use smokeless tobacco products or sometimes currently use (+1), currently use daily (+2) * Currently consume alcohol daily (+1) * Waist circumference 81-90 cm (women)/91-100 cm (men) (+1), >90 cm (women)/>100cm (men) (+2) * Physical activity <150 minutes per week (+1) * Parent and/or sibling with high blood pressure, diabetes, or heart disease (+2) |
| Eligible adults | Other | Behavioral: Ambuja Cement Foundation's Non Communicable Disease ProgramGroup 1: All adults ≥30 years old living in the 12 target villages who meet eligibility criteria and provide informed consent |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Reside in the study area (12 villages in Bathinda District of Punjab, India). "Residence" will be defined as sleeping in a house in that village on a typical weeknight.
Key exclusion criteria (4 listed)
- • Plan to move permanently out of the study area in the next 12 months.
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 |
|---|---|---|
| Ambuja Cement Foundation's Non Communicable Disease ProgramGovernment level: Strengthening linkages with Govt; Ensuring availability \& affordability of NCD diagnostics and treatment; Establishing a follow-up mechanism with patients to ensure continuity of care \& medication compliance Provider level: Capacity building of frontline workers; Promotion of interface between community \& service provider Community level: Screening of hypertension \& diabetes for all adults ≥30 years in the village in coordination with Govt under 'population based screening'; Create awareness of modifiable risk factors and lifestyle change among high-risk population; Community mobilization \& active participation in various health marker days; Formation of support groups, women's groups, self help groups, with involvement of people living with NCDs Individual level: Behavior change communication with messages on NCD risk factors; Nutrition awareness on healthy and unhealthy food practices | Behavioural | Eligible adults, High Risk |
Primary outcome
Fasting Blood Glucose
Time frame: Four measures over 12 months
Fasting blood glucose will be measured using a point-of-care device
Systolic and Diastolic blood pressure
Time frame: Four measures over 12 months
Blood pressure will be measured using an automatic digital blood pressure machine
Body weight
Time frame: Four measures over 12 months
Body weight will be measured using a weighing scale
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 14 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambuja Cement Foundation's Non Communicable Disease Program in people with Non Communicable Diseases and Blood Pressure, run by Harvard School of Public Health (HSPH) at 1 site in India.
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 3 inclusion and 4 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 14 Feb 2025. 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 India. 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?
Fasting Blood Glucose (time frame: Four measures over 12 months). 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?
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 14 Feb 2025.