Study Protocol Feasibility and Pilot Trial of Brief Behaviour Change Counseling Using Five as and a Guiding Style From Motivational Interviewing on Lifestyle Behaviour in Patients With Hypertension or Diabetes in Mangochi, Malawi: BBCC+5 A's+GS Quasi-experimental Study Protocol
Abstract BackgroundDiabetes and hypertension and their lifestyle risk factors are on the increase in sub-Saharan Africa. Despite positive effects of behavioural intervention such as brief behaviour change in some African countries, there has not been significant implementation of the same in Malawi. We therefore decided to conduct this study aimed at implementing brief behaviour change counseling using 5 As and a guiding style from motivational interviewing (BBCC + 5 As + GS) in Mangochi with specific objectives of determining its feasibility and its efficacy.MethodsThis study is a mixed, quasi-experimental, feasibility study which comprises an exploratory 2 arms quantitative part with a qualitative component at the end of the trial. Fifty consecutive eligible participants will be recruited among patients attending two Non-Communicable Diseases (NCDs) clinics (Mangochi District Hospital and Monkey Bay Rural Hospital) and allocated equally to intervention group (receiving brief behaviour change counseling) and non-intervention (routine care only). In addition to a qualitative process evaluation at the end of the third time points, the groups will be assaessed at baseline - 12 weeks and 24 weeks’ post-implementation on the following factors: feasibility outcomes, sociodemographic factors, lifestyle factors, body mass index, waist circumference, hip to waist ratio, lipids (cholesterols, triglycerides), glycated hemoglobin, quality of life domains and theory of planned behaviour constructs’ changes and process evaluation. DiscussionIt is anticipated that the results of this pilot trial will help to determine and assess the feasibility and the provisional efficacy of this intervention, as well as key useful elements of this trial in order to develop it for further exploration in a larger trial.Registration and status of the trialTrial registration: ClinicalTrials.gov, NCT04625452, registered 12 November 2020, https://clinicaltrials.gov/ct2/show/NCT04625452, and recruitment: June 1, 2021.