RESUMO
AIM: Evidence to show whether lifestyle intervention programs are beneficial for patients with diabetes in resource-limited countries is lacking. The present study assessed the additional efficacy of a structured lifestyle education program, as compared to the current standard of diabetic care in Rwanda. METHODS: 251 consecutive adult patients attending a tertiary diabetic care practice were randomly assigned to either an intervention group (standard of care plus monthly lifestyle group education sessions of 45min duration) or to a control group. The primary outcome was between-groups difference in glycated hemoglobin (HbA1c) observed after 12-months follow up. Outcome measures in the intervention and control groups were compared using the ANCOVA test with a two-sided significance of 5%. RESULTS: Of the 251 subjects recruited, 223 were included in the analysis; of whom 115 were assigned to the intervention group, and 108 to the control group. After 12-months, the median HbA1c levels reduced by 1.70 (95% CI: -2.09 to -1.31; p<0.001) in the intervention group; and by 0.52 (95% CI: -0.95 to -0.10; p=0.01) in the control group. The difference in HbA1c reduction between the intervention and control groups was statistically significant (p<0.001) after adjustment for subjects' age, sex, education level, BMI, diabetes duration and diabetic medications. CONCLUSIONS: This study demonstrated that a structured lifestyle group education program for people with diabetes is an attractive option in a resource-limited setting, as it showed significant benefits in improved glycemic control over a 12-month period. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02032108.