A Lifestyle Intervention for Type 2 Diabetes Patients in Kuwait and Its Impact on Glycaemic Control

Diabetes, Type 2 Clinical Trial

Official title:

A Lifestyle Intervention for Type 2 Diabetes Patients in Kuwait and Its Impact on Glycaemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397225
• Other study ID #: 13/53
• Status: Completed
• Phase: N/A
• First received: December 29, 2017
• Last updated: January 12, 2018
• Start date: November 15, 2013
• Est. completion date: February 29, 2016

Study information

• Verified date: January 2018
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 29, 2016
• Est. primary completion date: January 29, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of major disabilities such as cardiovascular disease (CVD), an inability to walk, cancer, and Chronic Obstructive Pulmonary Diseases (COPD).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Noninsulin-Dependent
• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Behavioral:
• Lifestyle intervention
The educational sessions and individual sessions including dietary management and physical activity advices.

Locations

Country	Name	City	State
Kuwait	Al-Rehab polyclinic	Kuwait	Farwaniyah
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Countries where clinical trial is conducted

Kuwait,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Diabetes control	12 months

External Links

•   The reference is related to the background of the study