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

Hypertension Clinical Trial

— BBCC+5A's+GS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04625452
• Other study ID #: P.08/18/2454
• Secondary ID: 5U24HL136791-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2020
• Source: University of Malawi College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 30, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Life Style

Intervention

Behavioral:
• BBCC+5A's+GS
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.

Locations

Country	Name	City	State
Malawi	Mangochi District Hospital	Mangochi	Eastern-Region

Sponsors (2)

Lead Sponsor	Collaborator
University of Malawi College of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Malawi, 

References & Publications (9)

Amberbir A, Lin SH, Berman J, Muula A, Jacoby D, Wroe E, Maliwichi-Nyirenda C, Mwapasa V, Crampin A, Makwero M, Singogo E, Phiri S, Gordon S, Tobe SW, Masiye J, Newsome B, Hosseinipour M, Nyirenda MJ, van Oosterhout JJ. Systematic Review of Hypertension and Diabetes Burden, Risk Factors, and Interventions for Prevention and Control in Malawi: The NCD BRITE Consortium. Glob Heart. 2019 Jun;14(2):109-118. doi: 10.1016/j.gheart.2019.05.001. — View Citation

Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. — View Citation

Cleland C, Ferguson S, Ellis G, Hunter RF. Validity of the International Physical Activity Questionnaire (IPAQ) for assessing moderate-to-vigorous physical activity and sedentary behaviour of older adults in the United Kingdom. BMC Med Res Methodol. 2018 Dec 22;18(1):176. doi: 10.1186/s12874-018-0642-3. — View Citation

Colbourn T, Masache G, Skordis-Worrall J. Development, reliability and validity of the Chichewa WHOQOL-BREF in adults in Lilongwe, Malawi. BMC Res Notes. 2012 Jul 3;5:346. doi: 10.1186/1756-0500-5-346. — View Citation

de Granda-Orive JI, Pascual-Lledó JF, Asensio-Sánchez S, Solano-Reina S, García-Rueda M, Martínez-Muñiz MÁ, Lázaro-Asegurado L, Bujulbasich D, Pendino R, Luhning S, Cienfuegos-Agustín I, Jiménez-Ruiz CA. Fagerström Test and Heaviness Smoking Index. Are they Interchangeable as a Dependence Test for Nicotine? Subst Use Misuse. 2020;55(2):200-208. doi: 10.1080/10826084.2019.1660680. Epub 2019 Sep 13. — View Citation

De Vet E, de Nooijer J, de Vries NK, Brug J. The Transtheoretical model for fruit, vegetable and fish consumption: associations between intakes, stages of change and stage transition determinants. Int J Behav Nutr Phys Act. 2006 Jun 19;3:13. — View Citation

Malan Z, Mash B, Everett-Murphy K. Evaluation of a training programme for primary care providers to offer brief behaviour change counselling on risk factors for non-communicable diseases in South Africa. Patient Educ Couns. 2016 Jan;99(1):125-31. doi: 10.1016/j.pec.2015.08.008. Epub 2015 Aug 14. — View Citation

Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253. — View Citation

Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline in body weight at 12 weeks	The measure will be assessed in the morning before the clinic, participants will be weighted in light clothes, barefoot using bathroom scale and will be recorded to the nearest 0.1 kg. Change will be calculated as the difference of weight recorded at baseline and weight recorded at 12 weeks.	[Time frame: baseline and 12 weeks]
Other	Change of body weight from 12 weeks at 24 weeks	The measure will be assessed in the morning before the clinic, participants will be weighted in light clothes, barefoot using bathroom scale and will be recorded to the nearest 0.1 kg. Change will be the difference of weight recorded at 12 weeks and weight recorded at 24 weeks.	[Time frame 12 and 24 weeks]
Other	Mean's change from baseline in Body Mass Index at 12 weeks	The measure will be assessed after measurements of weight (kilograms) and height (meters) by dividing the weight square by the root-square of height (in meters). The values of below 18.5= underweight, 18.5-25= healthy weight, 25-29.9= overweight, and 30-35 = Grade I, 35-40: Grade II.,, = 40: Grade III. Change will be the difference of BMI calculated at baseline and at 12 weeks. The higher the figure after 25, the worse the outcome.	[Time Line: baseline and 12 weeks]
Other	Mean's Change from 12 weeks in Body Mass Index to 24 weeks	The measure will be assessed after measurements of weight (kilograms) and height (meters) by dividing the weight square by the root-square of height (in meters). The values of below 18.5= underweight, 18.5-25= healthy weight, 25-29.9= overweight, and 30-35 = Grade I, 35-40: Grade II.,, = 40: Grade III.; Change will be the difference of BMI calculated at 12 weeks with the figure at 24 weeks. The higher the figure after 25, the worse the outcome. The higher the figure after 25, the worse the outcome	[Time Line: 12 weeks and 24 weeks]
Other	Means' Change from baseline in Body Mass Index to 24 weeks	The measure will be assessed after measurements of weight (kilograms) and height (meters) by dividing the weight square by the root-square of height (in meters). The values of below 18.5= underweight, 18.5-25= healthy weight, 25-29.9= overweight, and 30-35 = Grade I, 35-40: Grade II.,, = 40: Grade III. Change will be the difference of BMI calculated at baseline with the figure at 24 weeks. The higher the figure after 25, the worse the outcome	[Time Frame: baseline and 24 weeks]
Other	Means' Change in waist -to- hip ratio at 12 weeks	Hip measurements were taken using a tape-measure placed horizontally at the point of maximum circumference over the buttocks. Measurements were taken to the nearest 0.1 cm.	[Time Line: baseline and 12 weeks]
Other	Mean's change in Mean waist-to-hip ratio (WHR) at 12 weeks	The measure will be assessed by dividing the waist circumference (using a tape-measure placed horizontally at the point between the iliac crest process and the lower margin of the last palpable rib in a patient standing on deep respiratory) by the hip circumference (Hip measurements were taken using a tape-measure placed horizontally at the point of maximum circumference over the buttocks) on a standing-up participants in deep expiration.; The normal range value is 0.80- 0.75. High values Change will be the difference of WHR calculated at baseline with the figure at 24 weeks.	[ Time Frame: baseline and 12 weeks]
Other	Mean's change in Mean waist-to-hip ratio at 24 weeks	The measure will be assessed by dividing the waist circumference (using a tape-measure placed horizontally at the point between the iliac crest process and the lower margin of the last palpable last rib in a patient standing on deep respiratory) by the hip circumference (Hip measurements were taken using a tape-measure placed horizontally at the point of maximum circumference over the buttocks) on a standing-up participants in deep expiration.; The normal range value from 0.80 to 0.70 More than……… central obesity. Change will be the difference of WRH calculated at 12 weeks and that at 24 weeks.	[ Time Frame: baseline and 24 weeks]
Other	Means' Change from baseline in pulse rate using an electronic blood pressure machine	This measure was assessed in the morning before the clinic alongside with the blood pressure recording through an electronic machine which is recording concurrently the blood pressure reading and the pulse rate. The normal values vary between 60-100, beyond which we have a tachycardia in adults, and below we note a bradycardia.; The value change was calculated as the value recorded at baseline minus the value recorded before any clinical examination at 12 weeks.	[Time frame: baseline and 12 weeks]
Other	Means' change from 12 weeks in pulse rate using an electronic blood pressure machine	This measure was assessed in the morning in patient relaxed in seating position before the clinic alongside with the blood pressure. The third recorded pulse rate's reading from the battery powered digital blood pressure machine was recorded. The normal values varied between 60-100, beyond which we have a tachycardia in adults, and below we note a bradycardia.; The value change was calculated as the value recorded at 12 weeks minus the value recorded at 24 weeks.	[Time frame: 12 and 24 weeks]
Other	34. Means' change from baseline in the mean pulse rate to 24 weeks using an electronic blood pressure machine	This measure was assessed in the morning before the clinic alongside with the blood pressure. The third recorded pulse rate's reading from the battery powered digital blood pressure machine was recorded. The normal values vary between 60-100, beyond which we have a tachycardia in adults, and below we note a bradycardia.; The value change was calculated as the value recorded at baseline minus the value recorded before at 24 weeks.	[Time frame: baseline and 24 weeks]
Other	35. Means' Change from baseline in the seated through cuff mean systolic blood pressure (SBP) from baseline to 12 weeks	The difference of the mean of third and second recorded systolic blood pressure readings on a seated relaxed patient from the battery powered digital blood pressure machine was recorded.	[Time Frame: baseline and 12 weeks]
Other	Mean's change from 12 weeks in the seated patient through cuff mean systolic blood pressure from 12 to 24 weeks	The difference of the means of third and second recorded systolic blood pressure readings of the 12 and 24 weeks on a seated relaxed patient from the battery powered digital blood pressure machine was recorded.	[Time Frame: 12 weeks and 24 weeks]
Other	Mean's change from baseline in the seated through cuff mean systolic blood pressure (SBP) from baseline to 12 weeks	The difference of the mean of third and second recorded systolic blood pressure readings on a seated relaxed patient from the battery powered digital blood pressure machine was recorded.	[Time Frame: baseline and 12 weeks]
Other	Mean's change from baseline in the seated patient through cuff mean systolic blood pressure from 0 to 24 weeks	The difference of the means of third and second recorded systolic blood pressure readings of the 0 and 24 weeks on a seated relaxed patient from the battery powered digital blood pressure machine was recorded.	[Time Frame: baseline and 24 weeks]
Other	Mean's change from baseline in the seated through cuff mean diastolic blood pressure (SBP) from baseline to 12 weeks	The difference of the mean of third and second recorded diastolic blood pressure readings on a seated relaxed patient from the battery powered digital blood pressure machine was recorded.	[Time Frame: baseline and 12 weeks]
Other	Mean's change from 12 weeks to 24 weeks in the seated patient through cuff mean diastolic blood pressure	The difference of the means of third and second recorded diastolic blood pressure readings of the 12 and 24 weeks on a seated relaxed patient from the battery powered digital blood pressure machine was recorded.	[Time Frame: 12 weeks and 24 weeks]
Other	Means' change from baseline in the seated patient through cuff mean diastolic blood pressure from 0 to 24 weeks	The difference of the means of third and second recorded systolic blood pressure readings of the 0 and 24 weeks on a seated relaxed patient from the battery powered digital blood pressure machine was recorded.	[Time Frame: baseline and 24 weeks]
Other	Means' change from baseline in the level of fasting blood sugar (mg/dl)	Clinical chemistry laboratory test of blood sugar assesses using blood samples. The normal values are between 70 and 115 mg/dl. FBS= 115 = abnormal	[Time-line: baseline, 12 weeks]
Other	Means change from 12 weeks in the level of fasting blood sugar (mg/dl)	Clinical chemistry laboratory test of blood sugar assessment using blood samples. The normal values are between 70 and 115 mg/dl. FBS= 115 = abnormal.	[Time-line: 12 weeks, 24 weeks]
Other	Means change from baseline in the level of fasting blood sugar (mg/dl)	Clinical chemistry laboratory test of blood sugar assessment using blood samples. The normal values are between 70 and 115 mg/dl. FBS= 115 = abnormal	[Time-line: 12 weeks, 24 weeks]
Other	Means change from baseline to 12 weeks in the level of total cholesterol (TC) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 200 mg/dl; beyond which you have hypercholesterolemia	[Time line: baseline, 12 weeks]
Other	Means change from 12 weeks to 24 in the level of total cholesterol (TC) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 200 mg/dl; beyond which you have hypercholesterolemia	[Time line: 12 weeks and 24 weeks]
Other	Means change from baseline to 24 weeks in the level of total cholesterol (TC) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values < 200 mg/dl; beyond which you have hypercholesterolemia	[Time line: baseline, 24 weeks]
Other	Means change from baseline to 12 weeks in the level of High density lipoproteins (HDL) (mg /dl)	Change from baseline to 12 weeks in the level of high density lipoproteins (HDL) (mmol/dl) Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = >1.15 millimole per deciliter; beyond which you have high HDL	[Time line: baseline, 12 weeks]
Other	Means change from 12 weeks to 24 in the level of High density lipoproteins (HDL) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 150 mg/dl; beyond which you have high HDL.	[Time line: 12 weeks and 24 weeks]
Other	Means change from baseline to 24 weeks in the level of High density lipoproteins (HDL) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 150 mg/dl; beyond which you have high HDL	[Time line: baseline, 24 weeks]
Other	Means change from baseline to 12 weeks in the level of low density lipoproteins (LDL) (mg/dl)	Change from baseline to 12 weeks in the level of low density lipoproteins (LDL) (mg/dl) Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 150 mg/dl; beyond which you have high LDL.	[Time line: baseline, 12 weeks]
Other	Means change from 12 weeks to 24 in the level of low density lipoproteins (LDL) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 150 mg/dl; beyond which you have high LDL.	[Time line: 12 weeks and 24 weeks]
Other	Means change from baseline to 24 weeks in the level of Low density lipoproteins (LDL) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 150 mg/dl; beyond which you have high LDL	[Time line: baseline, 24 weeks]
Other	Means change from baseline to 12 weeks in the level of triglycerides (TGC) (mg/dl)	Change from baseline to 12 weeks in the level of triglycerides (TGC) (mg/dl) Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 203.5 mg/dl; beyond which you have high TGC	[Time line: baseline, 12 weeks]
Other	Means change from 12 weeks to 24 in the level of triglycerides (TGC) (mg/dl)	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 203 mg/dl; beyond which you have high TGC	[Time line: 12 weeks and 24 weeks]
Other	Means change from baseline to 24 weeks in the level of triglycerides (TGC) (mg/dl).	Clinical chemistry laboratory test of lipids products assessment using blood sample. The normal value is values = 203.5 mg/dl; beyond which you have high TGC	[Time line: baseline, 24 weeks]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]

External Links

•   book website used for training of health workers in brief behavior change counseling in South Africa . Which we adopted for our study.