Skip to main content
OpenTrials
Completed

NCT Number: NCT03397225

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Al-Rehab polyclinic, Kuwait City, Farwaniyah, Kuwait

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lifestyle Intervention

Behavioral

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

Other names: Dietary and physical activity advices

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 12 months

    Diabetes control

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 11, 2018
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.