- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04625452
Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants (BBCC+5A's+GS)
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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
- 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).
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Eastern-Region
-
Mangochi, Eastern-Region, Малави, 42
- Mangochi District Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: 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)
|
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.
Другие имена:
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Без вмешательства: 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)
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
A measure of participants recruited (recruitment rate)
Временное ограничение: [Time frame: through study completion, an average of 24 weeks]
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The number of individuals recruited from those eligible
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[Time frame: through study completion, an average of 24 weeks]
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Number participants who consented to take part in the study
Временное ограничение: [Time frame: through study completion, an average of 24 weeks]
|
The number of participants who accepted to take part in the study from those deemed eligible for the study
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[Time frame: through study completion, an average of 24 weeks]
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Proportion of participants who completed the study during the 12 weeks' period
Временное ограничение: [ time frame: up to 12 weeks]
|
The number of participants who were able to complete each PROM divided by the total number of participants at 12 weeks
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[ time frame: up to 12 weeks]
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Proportion of participants who completed the study during the 24 weeks' period
Временное ограничение: [ Time frame: through study completion, an average of 24 weeks]
|
The number of participants who were able to complete each PROM divided by the total number of participants at 24 weeks
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[ Time frame: through study completion, an average of 24 weeks]
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Proportion of participants retained in the study
Временное ограничение: [ Time frame: through study completion, an average of 24 weeks]
|
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
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[ Time frame: through study completion, an average of 24 weeks]
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Proportions of participant's loss-to-follow-up at 12 weeks
Временное ограничение: [ time frame: up to 12 weeks]
|
Participants who stop (withdraw/dropout) and did not attend the 12 weeks' follow-up visit by the total of recruited participants.
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[ time frame: up to 12 weeks]
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Loss-to-follow-up at 24 weeks
Временное ограничение: [ Time frame: through study completion, an average of 24 weeks]
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Participants who stop (withdraw/dropout) and did not attend the 24 weeks' follow-up visit
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[ Time frame: through study completion, an average of 24 weeks]
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change from baseline in Alcohol Use Disorder Identification Test-C at 12 weeks
Временное ограничение: [ Time frame: at baseline and in 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
Временное ограничение: [ Time frame: through study completion, an average of 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
Временное ограничение: [ Time frame: at baseline and 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]
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Mean change in smoking from 12 weeks to 24 weeks using Short Fagerström Test for Nicotine dependence
Временное ограничение: [ Time frame: at 12 weeks and 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= ery high risk
|
[ Time frame: at 12 weeks and 24 weeks]
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16. Change from 12 weeks in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
Временное ограничение: [Timeframe baseline, 12 weeks]
|
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]
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Change from baseline in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
Временное ограничение: [Timeframe: baseline and in 6 weeks]
|
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
Временное ограничение: [Timeframe: baseline, 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
Временное ограничение: [Timeframe: 12 weeks through 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'
Временное ограничение: [Time frame: 12, 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
Временное ограничение: [time frame: baseline, 12 weeks]
|
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
|
[time frame: baseline, 12 weeks]
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Change of TTT sub-scales means from 12 to 24 weeks in the "Theoretical Model of Change" scores
Временное ограничение: [Time frame: 12 weeks and 24 weeks]
|
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
|
[Time frame: 12 weeks and 24 weeks]
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
change from baseline in body weight at 12 weeks
Временное ограничение: [Time frame: baseline and 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]
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Change of body weight from 12 weeks at 24 weeks
Временное ограничение: [Time frame 12 and 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]
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Mean's change from baseline in Body Mass Index at 12 weeks
Временное ограничение: [Time Line: baseline and 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]
|
Mean's Change from 12 weeks in Body Mass Index to 24 weeks
Временное ограничение: [Time Line: 12 weeks and 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]
|
Means' Change from baseline in Body Mass Index to 24 weeks
Временное ограничение: [Time Frame: baseline and 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]
|
Means' Change in waist -to- hip ratio at 12 weeks
Временное ограничение: [Time Line: baseline and 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]
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Mean's change in Mean waist-to-hip ratio (WHR) at 12 weeks
Временное ограничение: [ Time Frame: baseline and 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]
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Mean's change in Mean waist-to-hip ratio at 24 weeks
Временное ограничение: [ Time Frame: baseline and 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]
|
Means' Change from baseline in pulse rate using an electronic blood pressure machine
Временное ограничение: [Time frame: baseline and 12 weeks]
|
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]
|
Means' change from 12 weeks in pulse rate using an electronic blood pressure machine
Временное ограничение: [Time frame: 12 and 24 weeks]
|
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]
|
34. Means' change from baseline in the mean pulse rate to 24 weeks using an electronic blood pressure machine
Временное ограничение: [Time frame: baseline and 24 weeks]
|
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]
|
35. Means' Change from baseline in the seated through cuff mean systolic blood pressure (SBP) from baseline to 12 weeks
Временное ограничение: [Time Frame: baseline and 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]
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Mean's change from 12 weeks in the seated patient through cuff mean systolic blood pressure from 12 to 24 weeks
Временное ограничение: [Time Frame: 12 weeks and 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]
|
Mean's change from baseline in the seated through cuff mean systolic blood pressure (SBP) from baseline to 12 weeks
Временное ограничение: [Time Frame: baseline and 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]
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Mean's change from baseline in the seated patient through cuff mean systolic blood pressure from 0 to 24 weeks
Временное ограничение: [Time Frame: baseline and 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]
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Mean's change from baseline in the seated through cuff mean diastolic blood pressure (SBP) from baseline to 12 weeks
Временное ограничение: [Time Frame: baseline and 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]
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Mean's change from 12 weeks to 24 weeks in the seated patient through cuff mean diastolic blood pressure
Временное ограничение: [Time Frame: 12 weeks and 24 weeks]
|
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]
|
Means' change from baseline in the seated patient through cuff mean diastolic blood pressure from 0 to 24 weeks
Временное ограничение: [Time Frame: baseline and 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]
|
Means' change from baseline in the level of fasting blood sugar (mg/dl)
Временное ограничение: [Time-line: baseline, 12 weeks]
|
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]
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Means change from 12 weeks in the level of fasting blood sugar (mg/dl)
Временное ограничение: [Time-line: 12 weeks, 24 weeks]
|
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]
|
Means change from baseline in the level of fasting blood sugar (mg/dl)
Временное ограничение: [Time-line: 12 weeks, 24 weeks]
|
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]
|
Means change from baseline to 12 weeks in the level of total cholesterol (TC) (mg/dl)
Временное ограничение: [Time line: baseline, 12 weeks]
|
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]
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Means change from 12 weeks to 24 in the level of total cholesterol (TC) (mg/dl)
Временное ограничение: [Time line: 12 weeks and 24 weeks]
|
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]
|
Means change from baseline to 24 weeks in the level of total cholesterol (TC) (mg/dl)
Временное ограничение: [Time line: baseline, 24 weeks]
|
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]
|
Means change from baseline to 12 weeks in the level of High density lipoproteins (HDL) (mg /dl)
Временное ограничение: [Time line: baseline, 12 weeks]
|
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]
|
Means change from 12 weeks to 24 in the level of High density lipoproteins (HDL) (mg/dl)
Временное ограничение: [Time line: 12 weeks and 24 weeks]
|
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]
|
Means change from baseline to 24 weeks in the level of High density lipoproteins (HDL) (mg/dl)
Временное ограничение: [Time line: baseline, 24 weeks]
|
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]
|
Means change from baseline to 12 weeks in the level of low density lipoproteins (LDL) (mg/dl)
Временное ограничение: [Time line: baseline, 12 weeks]
|
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]
|
Means change from 12 weeks to 24 in the level of low density lipoproteins (LDL) (mg/dl)
Временное ограничение: [Time line: 12 weeks and 24 weeks]
|
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]
|
Means change from baseline to 24 weeks in the level of Low density lipoproteins (LDL) (mg/dl)
Временное ограничение: [Time line: baseline, 24 weeks]
|
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]
|
Means change from baseline to 12 weeks in the level of triglycerides (TGC) (mg/dl)
Временное ограничение: [Time line: baseline, 12 weeks]
|
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]
|
Means change from 12 weeks to 24 in the level of triglycerides (TGC) (mg/dl)
Временное ограничение: [Time line: 12 weeks and 24 weeks]
|
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]
|
Means change from baseline to 24 weeks in the level of triglycerides (TGC) (mg/dl).
Временное ограничение: [Time line: baseline, 24 weeks]
|
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]
|
Соавторы и исследователи
Следователи
- Директор по исследованиям: Adamson S Muula, PhD, Kamuzu University of Health Sciences
Публикации и полезные ссылки
Общие публикации
- 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. doi: 10.1001/archinte.158.16.1789.
- 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.
- Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- 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. doi: 10.1186/1479-5868-3-13.
- de Granda-Orive JI, Pascual-Lledo JF, Asensio-Sanchez S, Solano-Reina S, Garcia-Rueda M, Martinez-Muniz MA, Lazaro-Asegurado L, Bujulbasich D, Pendino R, Luhning S, Cienfuegos-Agustin I, Jimenez-Ruiz CA. Fagerstrom 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.
- 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.
- 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.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- P.08/18/2454
- 5U24HL136791-01 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- План статистического анализа (SAP)
- Отчет о клиническом исследовании (CSR)
- Аналитический код
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования BBCC+5A's+GS
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Gesynta Pharma ABCTC Clinical Trial Consultants AB; RISE Research Institutes of Sweden ABЗавершенный
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University of WashingtonNational Institute on Drug Abuse (NIDA)ЗавершенныйПередозировка опиоидовСоединенные Штаты
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Gilead SciencesЗавершенныйНеалкогольный стеатогепатит (НАСГ)Канада, Соединенные Штаты, Гонконг, Соединенное Королевство, Швейцария, Новая Зеландия
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Gilead SciencesOno Pharmaceutical Co. LtdЗавершенныйХронический лимфолейкоз | Неходжкинской лимфомыСоединенное Королевство, Франция
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Gilead SciencesЗавершенныйНеалкогольный стеатогепатит (НАСГ) | Первичный склерозирующий холангит (ПСХ)Соединенные Штаты, Новая Зеландия
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Gilead SciencesЗавершенныйВИЧСоединенные Штаты, Новая Зеландия
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Gilead SciencesЗавершенныйВГС-инфекцияСоединенные Штаты, Германия, Новая Зеландия
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Gilead SciencesЗавершенныйВГС-инфекцияСоединенные Штаты, Новая Зеландия, Германия
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Gilead SciencesЗавершенныйВоспалительные заболеванияСоединенные Штаты, Новая Зеландия, Германия
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Gilead SciencesПрекращеноПервичный склерозирующий холангитСоединенные Штаты, Бельгия, Израиль, Испания, Соединенное Королевство, Австралия, Германия, Новая Зеландия, Дания, Франция, Япония, Швейцария, Австрия, Канада, Финляндия, Италия