Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants

Study Overview
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Brief Summary
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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

Detailed Description
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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. OBJECTIVES 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. 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: Design: mixed methods (pilot quasi-experimental and qualitative study) Settings: The study will take place at two sites: Mangochi District Hospital and Monkey Bay Community Hospital; Malawi. sample size: Purposeful sampling and successive eligible patients. Sample size: Efficacy study will be conducted on 50 patients. 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).

Official Title
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Feasibility and Efficacy of Lifestyle Risk Factors Through Brief Behaviour Change Counseling in NCD's Participants Using 5A's and a Guiding Style (BBCC+ 5A's +GS) in Mangochi, Southern Malawi

Conditions
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Hypertension, Diabetes, Life Style

Intervention / Treatment
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* Behavioral: BBCC+5A's+GS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18-65 years old, registered in the clinic at least for 6 months, been screened for at least 1 lifestyle risk factor, express willingness to participate in the study, being permanent resident in Mangochi District for at least 12 months from recruitment, and Fluent in Chichewa and/or Yao Exclusion Criteria: - present with any concomitant severe disease, being pregnant patient with an active Psychiatrics' comorbidity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group will be administered at 3, 12 and 24 weeks. The intervention consists in addition to normal care and distribution of printed education pamphlets, of an individual counseling based on lifestyle risk factors of diabetic or hypertensive participants themed around 5 points (ask, advice or alert, assess , assist and arrange). It will use a guiding style from motivational interviewing consisting of asking opened questions, summarizing patients, reflecting him his statements, and capture change words, and requesting for permission to introduce any new point. Normal care Participants allocated to normal care (control group) will receive standard care for diabetes or hypertension as per Malawi- government's NCD's guidelines: drugs, inconsistent unstructured advises regarding lifestyle behavior, opportunistic biological tests as per clinician's judgement.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBCC+5A's+GS<br>Brief behavior change counseling using 5A's + Guiding style (from motivational interviewing) + Printed education materials ( at baseline, 12 weeks, 24 weeks) | Behavioral: BBCC+5A's+GS<br>* It is a 5-steps intervention delivered in a motivational interviewing spirit. Clearly the five steps are asking about the behaviour risk factors, assessing the level of risk factors; providing information about the pros and cons of the behaviour in a neutral way; assessing the change by probing about the importance in and the confidence of changing the risk factor; assisting the patient to come-up with a road map about changing the risk factor, connecting the patient to support networks or drugs which can increase the likelihood to change; and arranging for the next visit. All this given by asking opened question to participant, active listening, summarizing what he is saying, evoking change through concepts or statements, empathy and asking permission to provide further information.<br>* Other names: Brief behavior change using 5A's and a guiding style from motivational interviewing;|
| No Intervention: Normal care<br>They will receive the normal care: simple advice on changing lifestyle risk factors + medications for diabetes or hypertension ( at baseline, 12 weeks, 24 weeks) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A measure of participants recruited (recruitment rate) | The number of individuals recruited from those eligible | [Time frame: through study completion, an average of 24 weeks] | 
| Number participants who consented to take part in the study | The number of participants who accepted to take part in the study from those deemed eligible for the study | [Time frame: through study completion, an average of 24 weeks] | 
| Proportion of participants who completed the study during the 12 weeks' period | The number of participants who were able to complete each PROM divided by the total number of participants at 12 weeks | [ time frame: up to 12 weeks] | 
| Proportion of participants who completed the study during the 24 weeks' period | The number of participants who were able to complete each PROM divided by the total number of participants at 24 weeks | [ Time frame: through study completion, an average of 24 weeks] | 
| Proportion of participants retained in the study | Proportion of participants who remained in the study during its full duration. The number of participants who are in the study at 6 months divided by the total number of patients who were recruited | [ Time frame: through study completion, an average of 24 weeks] | 
| Proportions of participant's loss-to-follow-up at 12 weeks | Participants who stop (withdraw/dropout) and did not attend the 12 weeks' follow-up visit by the total of recruited participants. | [ time frame: up to 12 weeks] | 
| Loss-to-follow-up at 24 weeks | Participants who stop (withdraw/dropout) and did not attend the 24 weeks' follow-up visit | [ Time frame: through study completion, an average of 24 weeks] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Alcohol Use Disorder Identification Test-C at 12 weeks | Audit-C is a validated, self-reported measure of perceived severity (quantity and frequency) of consumption of alcohol comprising 3 questions whose score gives a global score from the 3. The scoring system of AUDIT-C is as follow: frequency of drink containing alcohol (scores: 0-4); number of standard drinks on a day (scores: 0-4); and frequency of 5 or more standard drinks on any one occasion (scores: 0-4). This global score is either below 5 (non-harmful alcohol use), or from 5 and higher (harmful alcohol). The higher the score, the severe the drinking. | [ Time frame: at baseline and in 12 weeks] | 
| Alcohol Use Disorder Identification Test-C at 24 weeks | Mean change from baseline of Alcohol Use Disorder Identification Test among participants who were screened for harmful alcohol use with a score of 5 or more on AUDIT-C at 24 weeks. 9. Change from baseline in Alcohol Use Disorder Identification Test-C at 12 weeks Audit-C is a validated, self-reported measure of perceived severity (quantity and frequency) of consumption of alcohol comprising 3 questions whose score gives a global score from the 3. The scoring system of AUDIT-C is as follow: frequency of drink containing alcohol (scores: 0-4); number of standard drinks on a day (scores: 0-4); and frequency of 5 or more standard drinks on any one occasion (scores: 0-4). This global score is either below 5 (non-harmful alcohol use), or from 5 and higher (harmful alcohol). The higher the score, the severe the drinking. | [ Time frame: through study completion, an average of 24 weeks] | 
| Mean change in smoking from baseline to 12 weeks using Short Fagerström Test for Nicotine dependence among participants who are screened for smoking of any form (cigarettes, chewing, tobacco, pipe) and any amount out at 24 weeks | Fagertrom test using two questions for scoring related to time between walking-up and taking the first cigarettes (≤ 5 min= 3, 6-30 minutes=1, 31-60 minutes=3), and number of cigarettes taken per day (≤ 10=0, 11-20=1, 21-30=2, and ≥ 31=3). score varies from 0-6; 0-3=very low risk and 6= very high risk | [ Time frame: at baseline and 24 weeks] | 
| Mean change in smoking from 12 weeks to 24 weeks using Short Fagerström Test for Nicotine dependence | Mean change in smoking from baseline to 12 weeks using Short Fagerström Test for Nicotine dependence among participants who are screened for smoking of any form (cigarettes, chewing, tobacco, pipe) and any amount out at 24 weeks. Fagertrom test using two questions for scoring related to time between walking-up and taking the first cigarettes (≤ 5 min= 3, 6-30 minutes=1, 31-60 minutes=3), and number of cigarettes taken per day ( ≤ 10=0, 11-20=1, 21-30=2, and ≥ 31=3). score varies from 0-6; 0-3=very low risk and 6= ery high risk | [ Time frame: at 12 weeks and 24 weeks] | 
| 16. Change from 12 weeks in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref) | WHOQoL-Bref is a validated, self-reported instrument that is a general measure of perceived health status comprising 26 questions and yielding to 5 scores from 5 dimensions (with subscales) that assess 5 dimensions, namely: mobility; self-care; usual activities; pain/discomfort; and anxiety/ depression. Each dimension has 3 levels: no problems, some problems, and extreme problems, with scores of 1, 2, and 3 representing each level, respectively. The Global score is given by the sum of scores in each dimension/domain. The change will be the differences in scores between the figures at 24 weeks' menus figures at 12 weeks. The low the score, the worse the quality of life. Score is given by the sum of scores in each dimension/domain. The change will be the differences in scores between the figures at 12 weeks' menus figures at baseline. The low the score, the worse the quality of life. | [Timeframe baseline, 12 weeks] | 
| Change from baseline in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref) | WHOQoL is a validated, self-reported instrument that is a general measure of perceived health status comprising 26 questions and yielding to 5 scores from 5 dimensions (with subscales) that assess 5 dimensions, namely: mobility; self-care; usual activities; pain/discomfort; and anxiety/ depression. Each dimension has 3 levels: no problems, some problems, and extreme problems, with scores of 1, 2, and 3 representing each level, respectively. The Global score is given by the sum of scores in each dimension/domain. The change will be the differences in scores between the figures at 12 weeks' menus figures at baseline. The low the score, the worse the quality of life. | [Timeframe: baseline and in 6 weeks] | 
| Change in theory of planned behavior constructs' scores from baseline to 12 weeks | 18. Change in theory of planned behavior constructs' scores from baseline to 12 weeks The theory of planned behavior posits that he fact for someone to perform a given behavior (example: adopts a healthy diet) is guided by three kinds of considerations: beliefs about the likely consequences and experiences associated with the behavior (behavioral beliefs), beliefs about the normative expectations and behaviors of significant others (normative beliefs), and beliefs about the presence of factors that may facilitate or impede performance of the behavior (control beliefs). To measure those three components, a 7 points-scale was applied to each behavior with high number representing better (positive numbers)/worse outcomes (negative numbers). For attitude: bad-good; pleasant-unpleasant For perceived norm (agree-disagree; unlikely-likely), for perceived behavioral control (true-false, disagree-agree); intension (likely-unlikely, false-true) . The higher the score, the better | [Timeframe: baseline, 12 weeks] | 
| Change in theory of planned behavior constructs' means' difference from 12 to 24 weeks | The theory of planned behavior posits that he fact for someone to perform a given behavior (example: adopts a healthy diet) is guided by three kinds of considerations: beliefs about the likely consequences and experiences associated with the behavior (behavioral beliefs), beliefs about the normative expectations and behaviors of significant others (normative beliefs), and beliefs about the presence of factors that may facilitate or impede performance of the behavior (control beliefs). To measure those components, a 7 points-scale was applied to each behavior with high number representing better (positive numbers)/worse outcomes (negative numbers). Descriptive statistics per constructs were calculated. For attitude: bad-good; pleasant-unpleasant; for perceived norm (agree-disagree; unlikely-likely); for perceived behavioral control (true-false, disagree-agree); and intension (likely-unlikely, false-true) | [Timeframe: 12 weeks through 24 weeks] | 
| To assess the change of the the theory of planned behavior constructs between baseline scores and 24 weeks' | The theory of planned behavior posits that he fact for someone to perform a given behavior (example: adopts a healthy diet) is guided by three kinds of considerations: beliefs about the likely consequences and experiences associated with the behavior (behavioral beliefs), beliefs about the normative expectations and behaviors of significant others (normative beliefs), and beliefs about the presence of factors that may facilitate or impede performance of the behavior (control beliefs). To measure those components, a 7 points-scale was applied to each behavior with high number representing better (positive numbers)/worse outcomes (negative numbers). Descriptive statistics per constructs were calculated. For attitude: bad-good; pleasant-unpleasant; for perceived norm (agree-disagree; unlikely-likely); for perceived behavioral control (true-false, disagree-agree); and intension (likely-unlikely, false-true) | [Time frame: 12, 24 weeks] | 
| Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the Theoretical Model of Change score | Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the Theoretical Model of Change score TTM is a validated, self-report tool used to detect the level of change a participant has at a given time. For our case at baseline, 12 weeks, and at 24 weeks) scored from 1 to 5. Comparison of the scoring at 12 and at 24 will show if there has been change or not. The staging system of TTM is as follow STAGE 1; pre contemplation: I do not intend in the next 6 months stage 2. Contemplation: I intend to in the next 6 months stage 3. Preparation: I intend to in the next 30 days stage 4. Action: have been doing so for less than 6 months stage 5 maintenance I have been doing so for more than 6 months The higher the stage, the advanced the degree of changes and vice-versa. Same figure at two different time points= no progress on degree of behavior change. | [time frame: baseline, 12 weeks] | 
| Change of TTT sub-scales means from 12 to 24 weeks in the Theoretical Model of Change scores | Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the Theoretical Model of Change score TTM is a validated, self-report tool used to detect the level of change a participant has at a given time. For our case at baseline, 12 weeks, and at 24 weeks) scored from 1 to 5. Comparison of the scoring at 12 and at 24 will show if there has been change or not. The staging system of TTM is as follow STAGE 1; pre contemplation: I do not intend in the next 6 months stage 2. Contemplation: I intend to in the next 6 months stage 3. Preparation: I intend to in the next 30 days stage 4. Action: have been doing so for less than 6 months stage 5 maintenance I have been doing so for more than 6 months The higher the stage, the advanced the degree of changes and vice-versa. Same figure at two different time points= no progress on degree of behavior change. | [Time frame: 12 weeks and 24 weeks] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle, diabetics, hypertensives, brief behavior change, counseling, motivational interviewing, 5 A's