NCT04827615Completed
Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India
Source: ClinicalTrials.gov · Last updated 14 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 11322 (actual)
- First submitted
- 30 Mar 2021
- Start date
- 30 Jul 2019
- Primary completion date
- 30 Jan 2024
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Diseases
- Type 2 diabetes
- NCT number
- NCT04827615
What you commit to
- Study type: Interventional
- Participants enrolled: 11322
- From 30 Jul 2019 to the primary completion date, 30 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- • 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
Who the study is looking for
- • 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.
Age in the registry: 30 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ambuja Cement Foundation Coordinator of this site? Confirm its status | Bathinda | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.