Motivational interviewing to improve diabetes management for South Asian type 2 diabetic patients

ISRCTN	ISRCTN53472488
DOI	https://doi.org/10.1186/ISRCTN53472488
Protocol serial number	N0223119448
Sponsor	Department of Health (UK)
Funder	South Buckinghamshire NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 31/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Renu Bansil
Scientific

Dietetics Department
Wycombe Hospital
Queen Alexander Road
High Wycombe, Bucks
HP11 2TT
United Kingdom

Phone	+44 (0)1494 425286
Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Motivational interviewing to improve diabetes management for South Asian type 2 diabetic patients
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	People of South Asian descent with type 2 Diabetes.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	23/01/2003
Date of final enrolment	30/06/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Dietetics Department

High Wycombe, Bucks
HP11 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

31/03/2020: No publications found. All search options exhausted.