NCT03397225

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

December 29, 2017

Last Update Submit

January 12, 2018

Conditions

Diabetes Mellitus, Noninsulin-DependentDiabetes, Type 2

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Diabetes control

    12 months

Study Arms (3)

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.

Behavioral: Lifestyle intervention

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.

Behavioral: Lifestyle intervention

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.

Interventions

Lifestyle interventionBEHAVIORAL

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

Also known as: Dietary and physical activity advices
Control groupIntervention group

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Rehab polyclinic

Kuwait City, Farwaniyah, 18750571, Kuwait

Location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related 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.

    PMID: 20876408BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Mai Alhazzaa, Md, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

December 29, 2017

First Posted

January 11, 2018

Study Start

November 15, 2013

Primary Completion

January 29, 2015

Study Completion

February 29, 2016

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

GB(1)KU(1)