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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Body Weight; Blood Pressure; Diabetes Type 2; Lifestyle-related Condition; Behavior, Health; Blood Glucose, High; Blood Glucose, Low; Non Communicable Diseases
• Intervention / Treatment: Behavioral: Ambuja Cement Foundation's Non Communicable Disease Program

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 Type: Interventional
• Enrollment (Estimated): 11322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Punjab
    • Bhatinda, Punjab, India
      • Ambuja Cement Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: High Risk; 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)	Behavioral: Ambuja Cement Foundation's Non Communicable Disease Program; 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
Other: Eligible adults; Group 1: All adults ≥30 years old living in the 12 target villages who meet eligibility criteria and provide informed consent	Behavioral: Ambuja Cement Foundation's Non Communicable Disease Program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Glucose	Fasting blood glucose will be measured using a point-of-care device	Four measures over 12 months
Systolic and Diastolic blood pressure	Blood pressure will be measured using an automatic digital blood pressure machine	Four measures over 12 months
Body weight	Body weight will be measured using a weighing scale	Four measures over 12 months

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Ambuja Cement Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): July 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Evaluation; Diet; Body weight; Non Communicable Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight; Noncommunicable Diseases
• Other Study ID Numbers: IRB19-1217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No