Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04827615 |
| Other study ID # |
IRB19-1217 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2019 |
| Est. completion date |
July 30, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Harvard School of Public Health (HSPH) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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, 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.
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.
