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

NCT04827615 | Completed

• 1 other identifier: IRB19-1217
• Study Type: interventional
• Target: 11,322
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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)

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

Behavioral: Ambuja Cement Foundation's Non Communicable Disease Program

Interventions

Ambuja Cement Foundation's Non Communicable Disease Program BEHAVIORAL

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

Eligible adults; High Risk

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Ambuja Cement Foundation: collaborator

Study Sites (1)

Ambuja Cement Foundation

Bathinda, Punjab, India

Location

MeSH Terms

Conditions

Noncommunicable Diseases; Health Behavior; Diabetes Mellitus, Type 2; Mental Disorders; Body Weight

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: July 30, 2019
• Primary Completion: January 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 14, 2025

Record last verified: 2024-05

Locations

IN (1)