Evaluating the feasibility of a patient-centered intervention for diabetes self-management in Sri Lanka

Not Applicable

Completed

• Conditions: Type two Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12613000208707
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1.Cases of T2DM attending the Diabetes clinic for the first time but diagnosed within the last five years ;
2.Live within 10 kilometers of the clinic
3.Aged greater than or equal to 40 years and less than 70 years;
4.Confirmed T2DM based on Fasting Plasma Glucose of >140 mg/dl [7 mmol/L] or 2-hour post-glucose glucose of 11.1mmol/L (Sri Lanka Clinical guidelines)(ref);
5.Did not have any diabetic complications, have no history of cardiovascular disease and any serious illness;
6.Currently obtain oral therapy and/or insulin from a regular source (provided free of cost at public hospitals ) or have private means to purchase regular medication;
7.Willing for randomization.

Exclusion Criteria

pregnancy, have a serious illness, mental illness, cancer diagnosis in the last five years, or other conditions that may impede or prohibit participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c measured using serum assay[six months]

Secondary Outcome Measures

Name	Time	Method
(i) Diet: measured using Food Frequency Questionnaire [six months];(ii) Physical activity: measured using International Physical Activity Questionnaire (IPAQ) [six months];(iii) Blood pressure systolic and diastolic measured using a sphygmomanometer[six months];Lipid levels (LDL, HDL & TG) using serum assay[six months];Abdominal Adiposity: waist circumference and hip/waist ratio [six months];Self Efficacy: measured as Diabetes self efficacy (DES).[six months]