Translational research for Diabetes Self-Management in Sri Lanka: A randomized controlled trial.
OBJECTIVE
The study tested the hypothesis that a theory driven Diabetes Self-Management (DSM) intervention delivered by trained nurses would result in a clinically significant improvement in glycaemic control.


METHODS
Patients with an HbA1c >7.5% (58mmol/mol) and free of diabetes complications were enrolled into a randomized controlled trial (n=85). Intervention consisted of four sessions and monthly follow up for 6 months. Biochemical tests, and diet and physical activity assessments were done in both groups. Analysis of covariance was used to test the effectiveness of the intervention.


RESULTS
At 6 months, there was a significant difference (P=0.001) in HbA1c between the groups controlling for baseline values and other variables. Based on the primary outcome, 28% in the intervention group achieved the target value of 6.5% HbA1c, compared to 8% in the "usual care" group (P<0.001; η(2)=0.65). The reduction in total energy intake and increase in physical activity was significant in the intervention group between baseline and follow up.


CONCLUSIONS
The DSM intervention has resulted in a clinically significant impact on glycaemia, change in diet and physical activity, and has demonstrated the feasibility of using it within existing care arrangements in a developing country setting.
School of Public Health & Community Medicine, University of New South Wales, Sydney, NSW 2052, Australia. Electronic address: r.jayasuriya@unsw.edu.au.
R
R
Jayasuriya
School of Public Health & Community Medicine, University of New South Wales, Sydney, NSW 2052, Australia.
M J
MJ
Pinidiyapathirage
Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia; Diabetes Research Unit, Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
R
R
Jayawardena
Department of Public Health, University of Kelaniya, Faculty of Medicine, Ragama, Sri Lanka.
A
A
Kasturiratne
Faculty of Medicine, University of Colombo, Colombo 9, Sri Lanka.
P
P
de Zoysa
Medical Education Centre, University of Kelaniya, Faculty of Medicine, Ragama, Sri Lanka.
P
P
Godamunne
Department of Psychiatry, University of Peradeniya, Peradeniya, Sri Lanka.
S
S
Gamage
Department of Public Health, University of Kelaniya, Faculty of Medicine, Ragama, Sri Lanka.
A R
AR
Wickremasinghe
D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000451:nursing / Q000628:therapy*; D004032:Diet; D002149:Energy Intake; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D024802:Nurse's Role; D010353:Patient Education as Topic; D012648:Self Care; D013188:Sri Lanka; D013997:Time Factors; D057170:Translational Research, Biomedical; D016896:Treatment Outcome
D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
Diabetes self-management; Randomized controlled trial; Sri Lanka