A Lifestyle Intervention for Type 2 Diabetes Patients in Kuwait and Its Impact on Glycaemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes, treated with diabetes medications but not on insulin only, and who had other chronic diseases associated with diabetes, such as hypertension and hyperlipidaemia
排除标准
- •History of major disabilities such as cardiovascular disease (CVD), an inability to walk, cancer, and Chronic Obstructive Pulmonary Diseases (COPD).
研究组 & 干预措施
Intervention group
The lifestyle intervention, including educational sessions were given to the intervention group of diabetes patients. The educational sessions were scheduled every two weeks and a total of four sessions was provided to the intervention group, the session held in the lecture room at the polyclinic. Also, they were received two individual sessions including dietary and physical activity advice during the consultation session in the diabetic clinic at the beginning and at the end of the study.
干预措施: Lifestyle intervention (Behavioral)
Control group
Lifestyle intervention, including individual lifestyle consultation, including dietary and physical activity consultation at the beginning and the end of the study, two sessions. This is done after the screening of the participants in the diabetic clinic at the beginning and at the end of the study.
干预措施: Lifestyle intervention (Behavioral)
Anonymous data
The patients, n = 60, were recruited randomly and anonymously from the same diabetes clinic, and the HbA1c data was taken from the anonymous patients at two points over the 12-month study duration.
结局指标
主要结局
Hemoglobin A1c
时间窗: 12 months
Diabetes control
次要结局
未报告次要终点
研究者
Mai Alhazzaa, MD
PhD student
University of Reading