Effectiveness of a Female Community Health Volunteer-Delivered Intervention in Reducing Blood Glucose Among Adults With Type 2 Diabetes: An Open-Label, Cluster Randomized Clinical Trial

Abstract

Importance: Female community health volunteers (FCHVs) are frontline community health workers who have been a valuable resource in improving public health outcomes in Nepal, but their value is understudied in diabetes care.

Objective: To assess whether an FCHV-delivered intervention is associated with reduced blood glucose levels among adults with type 2 diabetes.

Design, setting, and participants: This community-based, open-label, 2-group, cluster randomized clinical trial with a 12-month delayed control group design was conducted in 14 clusters of a semiurban setting in Western Nepal. A total of 244 adults with type 2 diabetes were recruited between November 2016 and April 2017. The follow-up assessment was conducted at 12 months after enrollment. Data analysis was performed from January to February 2019.

Interventions: Seven clusters were randomized to the FCHV-delivered intervention in which 20 FCHVs provided home visits 3 times a year (once every 4 months) for health promotion counseling and blood glucose monitoring. If participants had blood glucose levels of 126 mg/dL or higher, the FCHVs referred them to the nearest health facility, and if participants were taking antihyperglycemic medication, they were followed up by the FCHVs for adherence to their medication. Seven clusters were randomized to usual care (control group).

Main outcomes and measures: The primary outcome was the change in mean fasting blood glucose from baseline to 12-month follow-up. Secondary outcomes included changes in mean systolic blood pressure, mean diastolic blood pressure, mean body mass index, percentage change in the proportion of low physical activity, harmful alcohol consumption, current smoking, low fruit and vegetable intake, and antihyperglycemic medication status.

Results: Of 244 participants, 120 women (56.6%) and 92 men (43.4%) completed the trial. At baseline, the mean (SD) age was 51.71 (8.77) years; 127 participants were in the intervention group, and 117 participants were in the control group (usual care). At baseline, the mean (SD) fasting blood glucose level was 156.06 (44.48) mg/dL (158.48 [45.50] mg/dL in the intervention group and 153.43 [43.39] mg/dL in the control group). At 12-month follow-up, the mean fasting blood glucose decreased by 22.86 mg/dL in the intervention group, whereas it increased by 7.38 mg/dL in the control group. The mean reduction was 27.90 mg/dL greater with the intervention (95% CI, -37.62 to -18.18 mg/dL; P < .001). In secondary outcome analyses, there was a greater decline in mean systolic blood pressure in the intervention group than in the control group (-5.40 mm Hg; 95% CI, -8.88 to -1.92 mm Hg; P = .002). There was detectable difference in the intake of antihyperglycemic medication between the groups (relative risk, 1.35; 95% CI, 1.1 to 1.74; P = .02).

Conclusions and relevance: These findings suggest that an FCHV-delivered intervention is associated with reduced blood glucose levels among adults with type 2 diabetes in a low-resource setting in Nepal.

Trial registration: ClinicalTrials.gov Identifier: NCT03304158.

Figure 1.. CONSORT Diagram for Cluster Randomized Clinical Trial (RCT) Showing Randomization Allocation, Follow-up, and Analysis

Figure 2.. Unadjusted Change in Fasting Blood Glucose From Baseline to Follow-up in Intervention and Control Groups

The difference in fasting blood glucose between baseline and follow-up was 7.38 mg/dL (to convert to millimoles per liter, multiply by 0.0555) for the control group and −22.86 mg/dL for the intervention group. Ends of the boxes denote the 25th and 75th percentiles, the horizontal lines inside the boxes denote the means, the error bars denote 95% CIs, and the circles denote outliers.

Figure 3.. Forest Plot of Differences in Mean Fasting Blood Glucose by Subgroup According to Different Characteristics of the Sample

The dashed line represents the line of no effect. Symbols show point estimates, and error bars denote 95% confidence limits. P values indicate subgroup interactions (obtained using mixed-effects models). To convert blood glucose to millimoles per liter, multiply by 0.0555. Body mass index is calculated as weight in kilograms divided by height in meters squared. DBP indicates diastolic blood pressure; and SBP, systolic blood pressure.