Diabetes, Type 2 Clinical Trial
Official title:
A Lifestyle Intervention for Type 2 Diabetes Patients in Kuwait and Its Impact on Glycaemic Control
This was an unblinded, randomised controlled study, the purpose of which was to investigate the impact of a structured health education intervention on the glycaemic control of Type 2 diabetes patients within a Kuwaiti cultural context.
The control group continued to receive routine clinical advice, in addition to the individual
session. The intervention group was enrolled in a structured group-based educational program
for the duration of the study (12 months). Physical, physiological and biochemical outcome
measures were assessed at baseline and then at a 12-month follow up. The total duration of
the study, including the recruitment, the screening, the pilot study, the educational
sessions and the follow-up, was 14 months altogether, from December 2014 to February 2016.
The study consisted of the following three phases.
- Phase 1: included the initial recruiting of diabetes patients at an Al-Rehab polyclinic
and the baseline assessment of their medical, dietary and physical activity history, in
addition to the biochemical assessment.
- Phase 2 (pilot study): Five patients were chosen from the recruited patients for a pilot
study to be monitored for one whole month (30 days) in order to evaluate the lifestyle
intervention's safety, its compliance to the educational sessions, and anticipated
barriers and results. Recruitment continued during the pilot study.
- Phase 3 (main study): This phase was based on recommending lifestyle intervention to the
intervention group of diabetes patients. The educational sessions were scheduled every
two weeks and a total of four sessions was provided. Both intervention and control
groups were received individual sessions at the beginning and at the end of the study.
Later, there was a follow up of the intervention and the control groups at the end of the
study, to measure the intervention's effectiveness and evaluate the results.
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