Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants (BBCC+5A's+GS)

実験的：BBCC+5A's+GS

Brief behavior change counseling using 5A's + Guiding style (from motivational interviewing) + Printed education materials ( at baseline, 12 weeks, 24 weeks)

行動：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.

他の名前：

• Brief behavior change using 5A's and a guiding style from motivational interviewing

介入なし：Normal care

They will receive the normal care: simple advice on changing lifestyle risk factors + medications for diabetes or hypertension ( at baseline, 12 weeks, 24 weeks)

A measure of participants recruited (recruitment rate)

The number of individuals recruited from those eligible

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

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

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

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

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.

Loss-to-follow-up at 24 weeks

Participants who stop (withdraw/dropout) and did not attend the 24 weeks' follow-up visit

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.

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.

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

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

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.

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.

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

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)

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)

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

1. STAGE 1; pre contemplation: I do not intend in the next 6 months
2. stage 2. Contemplation: I intend to in the next 6 months
3. stage 3. Preparation: I intend to in the next 30 days
4. stage 4. Action: have been doing so for less than 6 months
5. 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.

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

1. STAGE 1; pre contemplation: I do not intend in the next 6 months
2. stage 2. Contemplation: I intend to in the next 6 months
3. stage 3. Preparation: I intend to in the next 30 days
4. stage 4. Action: have been doing so for less than 6 months
5. 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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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

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

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

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

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.

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

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.

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.

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

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

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

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