HypertensionBBCC+5A's+GSNCT04625452
Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants
A study testing BBCC+5A's+GS in people with Hypertension and Diabetes, run by Kamuzu University of Health Sciences at 1 site in Malawi.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Diabetes, Life Style
- What is being tested?
- BBCC+5A's+GS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalawi
- Study dates
- 13 Aug 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - present with any concomitant severe disease,
- being pregnant
- patient with an active Psychiatrics' comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
- 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
- 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
- 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).
- Conditions
- Hypertension, Diabetes, Life Style
- Being tested
- BBCC+5A's+GS
- Keywords
- lifestyle, diabetics, hypertensives, brief behavior change, counseling, motivational interviewing, 5 A's
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBCC+5A's+GSBehavioural
Also called Brief behavior change using 5A's and a guiding style from motivational interviewing
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.
| Study group | Role | What they receive |
|---|---|---|
| BBCC+5A's+GS | Experimental | Brief behavior change counseling using 5A's + Guiding style (from motivational interviewing) + Printed education materials ( at baseline, 12 weeks, 24 weeks) Receives: Behavioral: BBCC+5A's+GS |
| Normal care | No intervention | They will receive the normal care: simple advice on changing lifestyle risk factors + medications for diabetes or hypertension ( at baseline, 12 weeks, 24 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A measure of participants recruited (recruitment rate)
The number of individuals recruited from those eligible
Measured: [Time frame: through study completion, an average of 24 weeks]
Number participants who consented to take part in the study
The number of participants who accepted to take part in the study from those deemed eligible for the study
Measured: [Time frame: through study completion, an average of 24 weeks]
Proportion of participants who completed the study during the 12 weeks' period
The number of participants who were able to complete each PROM divided by the total number of participants at 12 weeks
Measured: [ time frame: up to 12 weeks]
Proportion of participants who completed the study during the 24 weeks' period
The number of participants who were able to complete each PROM divided by the total number of participants at 24 weeks
Measured: [ Time frame: through study completion, an average of 24 weeks]
Proportion of participants retained in the study
Proportion of participants who remained in the study during its full duration. The number of participants who are in the study at 6 months divided by the total number of patients who were recruited
Measured: [ Time frame: through study completion, an average of 24 weeks]
Proportions of participant's loss-to-follow-up at 12 weeks
Participants who stop (withdraw/dropout) and did not attend the 12 weeks' follow-up visit by the total of recruited participants.
Measured: [ time frame: up to 12 weeks]
Loss-to-follow-up at 24 weeks
Participants who stop (withdraw/dropout) and did not attend the 24 weeks' follow-up visit
Measured: [ Time frame: through study completion, an average of 24 weeks]
Secondary outcomes (11)
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.
Measured: [ Time frame: at baseline and in 12 weeks]
Alcohol Use Disorder Identification Test-C at 24 weeks
Mean change from baseline of Alcohol Use Disorder Identification Test among participants who were screened for harmful alcohol use with a score of 5 or more on AUDIT-C at 24 weeks. 9. Change from baseline in Alcohol Use Disorder Identification Test-C at 12 weeks Audit-C is a validated, self-reported measure of perceived severity (quantity and frequency) of consumption of alcohol comprising 3 questions whose score gives a global score from the 3.
The scoring system of AUDIT-C is as follow: frequency of drink containing alcohol (scores: 0-4); number of standard drinks on a day (scores: 0-4); and frequency of 5 or more standard drinks on any one occasion (scores: 0-4). This global score is either below 5 (non-harmful alcohol use), or from 5 and higher (harmful alcohol). The higher the score, the severe the drinking.
Measured: [ Time frame: through study completion, an average of 24 weeks]
Mean change in smoking from baseline to 12 weeks using Short Fagerström Test for Nicotine dependence among participants who are screened for smoking of any form (cigarettes, chewing, tobacco, pipe) and any amount out at 24 weeks
Fagertrom test using two questions for scoring related to time between walking-up and taking the first cigarettes (≤ 5 min= 3, 6-30 minutes=1, 31-60 minutes=3), and number of cigarettes taken per day (≤ 10=0, 11-20=1, 21-30=2, and ≥ 31=3). score varies from 0-6; 0-3=very low risk and 6= very high risk
Measured: [ Time frame: at baseline and 24 weeks]
Mean change in smoking from 12 weeks to 24 weeks using Short Fagerström Test for Nicotine dependence
Mean change in smoking from baseline to 12 weeks using Short Fagerström Test for Nicotine dependence among participants who are screened for smoking of any form (cigarettes, chewing, tobacco, pipe) and any amount out at 24 weeks. Fagertrom test using two questions for scoring related to time between walking-up and taking the first cigarettes (≤ 5 min= 3, 6-30 minutes=1, 31-60 minutes=3), and number of cigarettes taken per day ( ≤ 10=0, 11-20=1, 21-30=2, and ≥ 31=3). score varies from 0-6; 0-3=very low risk and 6= ery high risk
Measured: [ Time frame: at 12 weeks and 24 weeks]
16. Change from 12 weeks in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
WHOQoL-Bref is a validated, self-reported instrument that is a general measure of perceived health status comprising 26 questions and yielding to 5 scores from 5 dimensions (with subscales) that assess 5 dimensions, namely: mobility; self-care; usual activities; pain/discomfort; and anxiety/ depression. Each dimension has 3 levels: no problems, some problems, and extreme problems, with scores of 1, 2, and 3 representing each level, respectively. The Global score is given by the sum of scores in each dimension/domain. The change will be the differences in scores between the figures at 24 weeks' menus figures at 12 weeks. The low the score, the worse the quality of life.
Score is given by the sum of scores in each dimension/domain. The change will be the differences in scores between the figures at 12 weeks' menus figures at baseline. The low the score, the worse the quality of life.
Measured: [Timeframe baseline, 12 weeks]
Change from baseline in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
WHOQoL is a validated, self-reported instrument that is a general measure of perceived health status comprising 26 questions and yielding to 5 scores from 5 dimensions (with subscales) that assess 5 dimensions, namely: mobility; self-care; usual activities; pain/discomfort; and anxiety/ depression. Each dimension has 3 levels: no problems, some problems, and extreme problems, with scores of 1, 2, and 3 representing each level, respectively.
The Global score is given by the sum of scores in each dimension/domain. The change will be the differences in scores between the figures at 12 weeks' menus figures at baseline. The low the score, the worse the quality of life.
Measured: [Timeframe: baseline and in 6 weeks]
Change in theory of planned behavior constructs' scores from baseline to 12 weeks
- 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
Measured: [Timeframe: baseline, 12 weeks]
Change in theory of planned behavior constructs' means' difference from 12 to 24 weeks
The theory of planned behavior posits that he fact for someone to perform a given behavior (example: adopts a healthy diet) is guided by three kinds of considerations: beliefs about the likely consequences and experiences associated with the behavior (behavioral beliefs), beliefs about the normative expectations and behaviors of significant others (normative beliefs), and beliefs about the presence of factors that may facilitate or impede performance of the behavior (control beliefs).
To measure those components, a 7 points-scale was applied to each behavior with high number representing better (positive numbers)/worse outcomes (negative numbers).
Descriptive statistics per constructs were calculated. For attitude: bad-good; pleasant-unpleasant; for perceived norm (agree-disagree; unlikely-likely); for perceived behavioral control (true-false, disagree-agree); and intension (likely-unlikely, false-true)
Measured: [Timeframe: 12 weeks through 24 weeks]
To assess the change of the the theory of planned behavior constructs between baseline scores and 24 weeks'
The theory of planned behavior posits that he fact for someone to perform a given behavior (example: adopts a healthy diet) is guided by three kinds of considerations: beliefs about the likely consequences and experiences associated with the behavior (behavioral beliefs), beliefs about the normative expectations and behaviors of significant others (normative beliefs), and beliefs about the presence of factors that may facilitate or impede performance of the behavior (control beliefs).
To measure those components, a 7 points-scale was applied to each behavior with high number representing better (positive numbers)/worse outcomes (negative numbers).
Descriptive statistics per constructs were calculated. For attitude: bad-good; pleasant-unpleasant; for perceived norm (agree-disagree; unlikely-likely); for perceived behavioral control (true-false, disagree-agree); and intension (likely-unlikely, false-true)
Measured: [Time frame: 12, 24 weeks]
Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the "Theoretical Model of Change" score
Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the "Theoretical Model of Change" score TTM is a validated, self-report tool used to detect the level of change a participant has at a given time. For our case at baseline, 12 weeks, and at 24 weeks) scored from 1 to 5. Comparison of the scoring at 12 and at 24 will show if there has been change or not.
The staging system of TTM is as follow
- STAGE 1; pre contemplation: I do not intend in the next 6 months
- stage 2. Contemplation: I intend to in the next 6 months
- stage 3. Preparation: I intend to in the next 30 days
- stage 4. Action: have been doing so for less than 6 months
- stage 5 maintenance I have been doing so for more than 6 months The higher the stage, the advanced the degree of changes and vice-versa. Same figure at two different time points= no progress on degree of behavior change.
Measured: [time frame: baseline, 12 weeks]
Change of TTT sub-scales means from 12 to 24 weeks in the "Theoretical Model of Change" scores
Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the "Theoretical Model of Change" score TTM is a validated, self-report tool used to detect the level of change a participant has at a given time. For our case at baseline, 12 weeks, and at 24 weeks) scored from 1 to 5. Comparison of the scoring at 12 and at 24 will show if there has been change or not.
The staging system of TTM is as follow
- STAGE 1; pre contemplation: I do not intend in the next 6 months
- stage 2. Contemplation: I intend to in the next 6 months
- stage 3. Preparation: I intend to in the next 30 days
- stage 4. Action: have been doing so for less than 6 months
- stage 5 maintenance I have been doing so for more than 6 months The higher the stage, the advanced the degree of changes and vice-versa. Same figure at two different time points= no progress on degree of behavior change.
Measured: [Time frame: 12 weeks and 24 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start13 Aug 2020
- Primary completion23 Feb 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group will be administered at 3, 12 and 24 weeks. The intervention consists in addition to normal care and distribution of printed education pamphlets, of an individual counseling based on lifestyle risk factors of diabetic or hypertensive participants themed around 5 points (ask, advice or alert, assess , assist and arrange). It will use a guiding style from motivational interviewing consisting of asking opened questions, summarizing patients, reflecting him his statements, and capture change words, and requesting for permission to introduce any new point. Normal care Participants allocated to normal care (control group) will receive standard care for diabetes or hypertension as per Malawi- government's NCD's guidelines: drugs, inconsistent unstructured advises regarding lifestyle behavior, opportunistic biological tests as per clinician's judgement.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kamuzu University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Adamson S Muula, PhD, Study director, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625452
- Sponsor's protocol ID
- P.08/18/2454
- Other IDs
- 5U24HL136791-01
- Acronym
- BBCC+5A's+GS
- Status last verified
- Nov 2020
- First submitted
- 19 Aug 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459De 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.
PubMed 16784520Bush 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.
PubMed 9738608de 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.
PubMed 31519135Cleland 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.
PubMed 30577770Malan 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.
PubMed 26324109Amberbir 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.
PubMed 31324364Colbourn 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.
PubMed 22759784Sim 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.
PubMed 22169081
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04625452
- Acronym / sponsor ID
- BBCC+5A's+GS / P.08/18/2454
- Conditions
- Hypertension, Diabetes, Life Style
- Keywords
- lifestyle, diabetics, hypertensives, brief behavior change, counseling, motivational interviewing, 5 A's
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kamuzu University of Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 23 Feb 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will be to assess the feasibility and the preliminary efficacy of brief behavior change counseling on lifestyle among diabetic and hypertensive patients
Detailed description
- 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
- 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
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group will be administered at 3, 12 and 24 weeks. The intervention consists in addition to normal care and distribution of printed education pamphlets, of an individual counseling based on lifestyle risk factors of diabetic or hypertensive participants themed around 5 points (ask, advice or alert, assess , assist and arrange). It will use a guiding style from motivational interviewing consisting of asking opened questions, summarizing patients, reflecting him his statements, and capture change words, and requesting for permission to introduce any new point. Normal care Participants allocated to normal care (control group) will receive standard care for diabetes or hypertension as per Malawi- government's NCD's guidelines: drugs, inconsistent unstructured advises regarding lifestyle behavior, opportunistic biological tests as per clinician's judgement.
| Arm | Type | Receives |
|---|---|---|
| BBCC+5A's+GS | Experimental | Behavioral: BBCC+5A's+GSBrief behavior change counseling using 5A's + Guiding style (from motivational interviewing) + Printed education materials ( at baseline, 12 weeks, 24 weeks) |
| Normal care | No intervention | –They will receive the normal care: simple advice on changing lifestyle risk factors + medications for diabetes or hypertension ( at baseline, 12 weeks, 24 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- - present with any concomitant severe disease,
- being pregnant
- patient with an active Psychiatrics' comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBCC+5A's+GSAlso: Brief behavior change using 5A's and a guiding style from motivational interviewingIt 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. | Behavioural | BBCC+5A's+GS |
Primary outcome
A measure of participants recruited (recruitment rate)
Time frame: [Time frame: through study completion, an average of 24 weeks]
The number of individuals recruited from those eligible
Number participants who consented to take part in the study
Time frame: [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
Proportion of participants who completed the study during the 12 weeks' period
Time frame: [ 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
Proportion of participants who completed the study during the 24 weeks' period
Time frame: [ 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
Proportion of participants retained in the study
Time frame: [ 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
Proportions of participant's loss-to-follow-up at 12 weeks
Time frame: [ 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.
Loss-to-follow-up at 24 weeks
Time frame: [ Time frame: through study completion, an average of 24 weeks]
Participants who stop (withdraw/dropout) and did not attend the 24 weeks' follow-up visit
11 secondary outcomes
Change from baseline in Alcohol Use Disorder Identification Test-C at 12 weeks
Time frame: [ Time frame: at baseline and in 12 weeks]
Alcohol Use Disorder Identification Test-C at 24 weeks
Time frame: [ 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
Time frame: [ Time frame: at baseline and 24 weeks]
Mean change in smoking from 12 weeks to 24 weeks using Short Fagerström Test for Nicotine dependence
Time frame: [ Time frame: at 12 weeks and 24 weeks]
16. Change from 12 weeks in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
Time frame: [Timeframe baseline, 12 weeks]
Change from baseline in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
Time frame: [Timeframe: baseline and in 6 weeks]
Change in theory of planned behavior constructs' scores from baseline to 12 weeks
Time frame: [Timeframe: baseline, 12 weeks]
Change in theory of planned behavior constructs' means' difference from 12 to 24 weeks
Time frame: [Timeframe: 12 weeks through 24 weeks]
To assess the change of the the theory of planned behavior constructs between baseline scores and 24 weeks'
Time frame: [Time frame: 12, 24 weeks]
Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the "Theoretical Model of Change" score
Time frame: [time frame: baseline, 12 weeks]
Change of TTT sub-scales means from 12 to 24 weeks in the "Theoretical Model of Change" scores
Time frame: [Time frame: 12 weeks and 24 weeks]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Background: PubMed 16784520De 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.
- Background: PubMed 9738608Bush 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.
- Background: PubMed 31519135de 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.
- Background: PubMed 30577770Cleland 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.
- Background: PubMed 26324109Malan 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.
- Background: PubMed 31324364Amberbir 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.
- Background: PubMed 22759784Colbourn 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.
- Background: PubMed 22169081Sim 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.
- book website used for training of health workers in brief behavior change counseling in South Africa . Which we adopted for our study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adamson S Muula, PhD study director
Kamuzu University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBCC+5A's+GS in people with Hypertension and Diabetes, run by Kamuzu University of Health Sciences at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A measure of participants recruited (recruitment rate) (time frame: [Time frame: through study completion, an average of 24 weeks]). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625452, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.