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

NCT ID: NCT03397225

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-15
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus, Noninsulin-Dependent; Diabetes, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: BEHAVIORAL

The educational sessions and individual sessions including dietary management and physical activity advices.

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.

Group Type: ACTIVE_COMPARATOR

Lifestyle intervention

Intervention Type: BEHAVIORAL

The educational sessions and individual sessions including dietary management and physical activity advices.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle intervention

The educational sessions and individual sessions including dietary management and physical activity advices.

Intervention Type: BEHAVIORAL

Other Intervention Names

Dietary and physical activity advices

Eligibility Criteria

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Mai Alhazzaa, MD

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai Alhazzaa, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

Al-Rehab polyclinic

Kuwait City, Farwaniyah, Kuwait

University of Reading

Reading, Berkshire, United Kingdom

Countries

Kuwait; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 20876408 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/20876408

The reference is related to the background of the study

Other Identifiers

13/53

Identifier Type: -

Identifier Source: org_study_id