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Clinical Trial Summary

The purpose of this study will be to assess the feasibility and the preliminary efficacy of brief behavior change counseling on lifestyle among diabetic and hypertensive patients


Clinical Trial Description

1. BACKGROUND Noncommunicables diseases (NCDs) are on the rise globally as well as in Malawi, alongside their behavioral modifiable risk factors. Behavioral intervention such as brief behavior change counseling using 5A's and a guiding style (BBCC + 5As +GS) has shown an effect on reducing these lifestyles risk factors. Their effectiveness varies between the behavioral technique used. But So far, available evidences of this effect are from western countries. Even implementation of these techniques has been done in some countries, but so far there is no information about their implementation in noncommunicable diseases field in Mangochi, even Malawi. Therefore, a really need to conduct this study in Mangochi, Southern Malawi. 2. OBJECTIVES 1. Overall objective: The primary objective of the study is to test the feasibility of the brief behavior change counseling using 5 A's and a guiding style from motivational interviewing which will be used for NCDs 'patients and assess its efficacy in improving lifestyle risk factors in NCDs' patients. 2. Specific objectives for this study are 1. to evaluate the feasibility of participating in a future quasi-experimental study of BBCC + 5A's + GS ; 2. to estimate the efficacy of BBCC + 5A's + GS from MI on lifestyle risk factors, theory constructs, quality of life domains; 3. to provide data on which to estimate the sample size required to detect a statistically significant difference between experimental and control groups; 4. and to explore experience of participants and care providers during the brief behaviour change counseling sessions to NCDs' patients in Mangochi 4. Methodology: 1. Design: mixed methods (pilot quasi-experimental and qualitative study) 2. Settings: The study will take place at two sites: Mangochi District Hospital and Monkey Bay Community Hospital; Malawi. 3. sample size: Purposeful sampling and successive eligible patients. Sample size: Efficacy study will be conducted on 50 patients. 4. Intervention: brief behaviour change using 5A's and a Guiding style from motivational interviewing will be administered to participants in the intervention group by trained counsellors (nurses). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04625452
Study type Interventional
Source University of Malawi College of Medicine
Contact
Status Active, not recruiting
Phase N/A
Start date August 13, 2020
Completion date March 30, 2021

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