Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Renu Bansil

ORCID ID

Contact details

Dietetics Department
Wycombe Hospital
Queen Alexander Road
High Wycombe
Bucks
HP11 2TT
United Kingdom
+44 (0)1494 425286

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0223119448

Study information

Scientific title

Acronym

Study hypothesis

Around 1.3 million people in Britain are currently diagnosed with diabetes (85% with type 2 diabetes). Diabetes is a life-long condition and the treatment and care required will vary over time. Individuals with diabetes need the necessary knowledge and skills to enable them to improve their blood glucose control and to make the lifestyle changes necessary to reduce their likelihood of developing the complications of diabetes. Individuals with type 2 diabetes are not dependent on insulin injections. They can manage their diabetes with diet, exercise and oral medication. Compared with the white population, type 2 diabetes is up to six times more common in people of South Asian descent (www.doh.gov.uk/nsf/diabetes).

Therefore the aim of this study is:
How effective is motivational interviewing in improving self-management of diabetes for men and women of South Asian origin who have been diagnosed with type 2 diabetes?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

Following ethical clearance and informed consent, a randomised-controlled trial will recruit two groups of Asian type 2 diabetic patients into:
a. Normal nutritional and lifestyle support (control), and
b. Motivational interviewing for nutritional and lifestyle support (treatment).

A sample size power analysis suggests that 28 participants per group will be adequate for the main outcome measures so at least 30 will be recruited per group to allow for attrition. The treatment group will engage in 20 to 30 minutes of motivational interviewing every two weeks. The control group will receive similar amounts of contact, but the total time allocation per patient will be less to concur with normal treatment. After three months the pre-treatment measures will be repeated and a two way analysis of variance design (P <0.05) used to test the treatment effect.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Psychometric Measures: Symptom reduction as measured by Diabetes Impact Measurement Scales. Quality of Life as measured by Diabetes Impact Measurement Scales. Increase in self-efficacy as measured by Diabetes Management Self-Efficacy Scale for Type 2 Diabetes. Increase in perceived control as measured by Perceived Control Scales. Clinical parameters: blood glucose (HbA1c), waist measurement, weight, body mass index (BMI).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

23/01/2003

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

People of South Asian descent with type 2 Diabetes.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

23/01/2003

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dietetics Department
High Wycombe, Bucks
HP11 2TT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

South Buckinghamshire NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes