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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Anonymous data | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | The educational sessions and individual sessions including dietary management and physical activity advices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Diabetes control | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai Alhazzaa, Md, PhD | University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Rehab polyclinic | Kuwait City | Farwaniyah | 18750571 | Kuwait | ||
| University of Reading |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20876408 | Background | Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334. |
| Label | URL |
|---|---|
| The reference is related to the background of the study | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Reading |
| Berkshire |
| RG6 6AP |
| United Kingdom |
| D004700 | Endocrine System Diseases |