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Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India

Primary Purpose

Non Communicable Diseases, Blood Pressure, Behavior, Health

Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Ambuja Cement Foundation's Non Communicable Disease Program
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non Communicable Diseases focused on measuring Evaluation, Non Communicable Disease, Body weight, Diet

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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

Sites / Locations

  • Ambuja Cement Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High Risk

Eligible adults

Arm Description

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)

Group 1: All adults ≥30 years old living in the 12 target villages who meet eligibility criteria and provide informed consent

Outcomes

Primary Outcome Measures

Fasting Blood Glucose
Fasting blood glucose will be measured using a point-of-care device
Systolic and Diastolic blood pressure
Blood pressure will be measured using an automatic digital blood pressure machine
Body weight
Body weight will be measured using a weighing scale

Secondary Outcome Measures

Full Information

First Posted
March 30, 2021
Last Updated
September 15, 2023
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Ambuja Cement Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04827615
Brief Title
Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India
Official Title
Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Ambuja Cement Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Communicable Diseases, Blood Pressure, Behavior, Health, Blood Glucose, High, Blood Glucose, Low, Diabetes Type 2, Lifestyle-related Condition, Body Weight
Keywords
Evaluation, Non Communicable Disease, Body weight, Diet

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
11322 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Risk
Arm Type
Other
Arm Description
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)
Arm Title
Eligible adults
Arm Type
Other
Arm Description
Group 1: All adults ≥30 years old living in the 12 target villages who meet eligibility criteria and provide informed consent
Intervention Type
Behavioral
Intervention Name(s)
Ambuja Cement Foundation's Non Communicable Disease Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Fasting Blood Glucose
Description
Fasting blood glucose will be measured using a point-of-care device
Time Frame
Four measures over 12 months
Title
Systolic and Diastolic blood pressure
Description
Blood pressure will be measured using an automatic digital blood pressure machine
Time Frame
Four measures over 12 months
Title
Body weight
Description
Body weight will be measured using a weighing scale
Time Frame
Four measures over 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • 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. Exclusion Criteria: • 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
Facility Information:
Facility Name
Ambuja Cement Foundation
City
Bhatinda
State/Province
Punjab
Country
India

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India

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