Effectifs of Lifestyle Education Programs on Diabetes control among Diabetic Patients at Kigali University teaching Hospital, Rwanda

Abstract

The increasing burden of non-communicable diseases (NCDs) such as type 2 diabetes mellitus is a serious global health problem. In Sub-Saharan Africa it is especially problematic as it places further economic strains on public health systems already exhausted by high rates of infectious and malnutrition-related diseases. Focusing on the individual determinants of diabetes is necessary to shift risk levels downwards and mitigate this growing health system challenge. In Rwanda, like in many other developing countries, accessibility to standardized diabetic health care is still limited. Evidence to show whether lifestyle intervention programs are beneficial for diabetic patients in resource-limited countries is unclear and remains an open question. We carried out the present study to assess the effects of an intensive lifestyle education program on diabetes control among patients attending an outpatient referral clinic in Kigali, Rwanda. Methods: The study is a randomized controlled trial evaluating the impact of an intensive lifestyle modification education program on diabetes control compared to standard of care treatment in Kigali, Rwanda. The study participants are adults, age 21 years or greater who have been diagnosed with diabetes mellitus who receive routine outpatient care at one of two internal medicine outpatient clinics at the Central Hospital of Kigali (CHUK). The participants were randomly assigned to an intervention group (standard of care plus monthly lifestyle counseling & education sessions lasting from 45 to 60 minutes) or to a control group (standard of care for diabetes in our setting which consists of monthly or bi-monthly medical follow up and individual counseling on dietary habits and lifestyle change delivered by attending physicians and/or nutritionists as per needed). The lifestyle education program for the intervention group was administered by a team of physicians, nurses, nutritionists and counselors who received special training for the purpose of this study. The primary outcome is between-groups difference in glycosylated hemoglobin (HbA1c). Secondary outcomes are within-group differences from baseline to six months in HbA1c, between-groups and endpoint-versus-baseline differences in blood pressure, weight, body mass index (BMI), lipid profiles and fasting plasma glucose. The follow up time for this study is one year, but the presented results relate a six-month interim analysis of the data. Results: The study included 251 diabetic patients. However, the presented results have been obtained from a six-month interim analysis, which included 186 subjects (91 in interventional group and 95 in the control group) who had completed six-month follow up period, representing 70% of total subjects included in the study. Of the 91 subjects allocated to the intervention group, 81 (89%) attended to at least three group education sessions. Forty six (50.5%) attended all the six pre-envisaged sessions. At baseline, the mean age was 51.5 years; females represented 69.4%; 64.4% had at least a secondary school education level; the mean duration of diabetes was 7.3 years, at least 50.5% had both diabetes and hypertension; and 26.9% were obese (BMI>29.9 kg/m2) The median glycosylated hemoglobin levels differed significantly between baseline and six-month follow up visit within both interventional and control groups. After six months follow up, the mean HbA1c levels reduced by 1.52 (95% CI: 1.05 to 1.98); p<0.001) in the interventional group; and by 0.91 (95% CI: 0.45 to 1.36); p: 0.003) in the control group. Although a trend towards greater HbA1c reduction was observed in the intervention group at six months, the difference in HbA1c reduction between the intervention and control groups was not significant (p = 0.064). The overall number of subjects achieving glycemic target goal (HbA1c<7%) increased from 16% at baseline to 35% at six-months with greater changes being observed in the intervention group (from 5% at baseline to 20.3% at six-month visit) compared to the control group (from 11% at baseline to 14.7% at six month visit). The six-month median fasting glucose levels, systolic blood pressure and diastolic blood pressure also differed significantly from baseline in the interventional group (p<0.001, 0.006, 0.002 respectively) but not in the control group (p: 0.411, 0.80, 0.42 respectively). Between groups median differences were statistically significant for diastolic blood pressure (p=0.047) but not for median fasting glucose levels (p=0.062) or systolic blood pressure (p=0.09), although a trend towards greater improvement in the lifestyle intervention group were seen for all three parameters. There were no significant improvements in weight within/across and between the two study groups. However, the median weight for people in the control group increased of 0.74 kg while those in the intervention had a median loss of 0.19 kg, suggesting that the intervention may, at least, have potential to prevent weight gain. Conclusions: Our study demonstrates that implementing an intensive lifestyle education program for diabetes control is feasible in a resource limited setting and is beneficial to diabetic patients. Although no statistically significant difference in glycemic control was observed among patients randomized to a lifestyle education program compared to individual diabetic counseling at six months, a trend towards great benefit with the lifestyle education program have been observed and could become amplified when at 1-year of follow up. Overall this study demonstrated that both forms of diabetes risk modification education strategies may be effective in Rwanda and other similar settings. Group-based diabetes education strategies are attractive in resource-constrained settings as they might have potential to allow for better use of the few available health professionals and have the ability to reach a greater number of patients. Further research looking at long-term effectiveness and sustainability of such programs in Sub-Saharan Africa are urgently needed. (ClinicalTrials.gov Identifier: NCT02032108).