Clinical trial NCT04625452: Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Diabetes
Life Style
Keywords: lifestyle
diabetics
hypertensives
brief behavior change
counseling
motivational interviewing
5 A's
Lead sponsor: Kamuzu University of Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed description: 1. BACKGROUND Noncommunicables diseases (NCDs) are on the rise globally as well as in Malawi, alongside their behavioral modifiable risk factors. Behavioral intervention such as brief behavior change counseling using 5A's and a guiding style (BBCC + 5As +GS) has shown an effect on reducing these lifestyles risk factors. Their effectiveness varies between the behavioral technique used. But So far, available evidences of this effect are from western countries. Even implementation of these techniques has been done in some countries, but so far there is no information about their implementation in noncommunicable diseases field in Mangochi, even Malawi. Therefore, a really need to conduct this study in Mangochi, Southern Malawi.
2. OBJECTIVES

   1. Overall objective: The primary objective of the study is to test the feasibility of the brief behavior change counseling using 5 A's and a guiding style from motivational interviewing which will be used for NCDs 'patients and assess its efficacy in improving lifestyle risk factors in NCDs' patients.
   2. Specific objectives for this study are

1. to evaluate the feasibility of participating in a future quasi-experimental study of BBCC + 5A's + GS ; 2. to estimate the efficacy of BBCC + 5A's + GS from MI on lifestyle risk factors, theory constructs, quality of life domains; 3. to provide data on which to estimate the sample size required to detect a statistically significant difference between experimental and control groups; 4. and to explore experience of participants and care providers during the brief behaviour change counseling sessions to NCDs' patients in Mangochi

4. Methodology:

1. Design: mixed methods (pilot quasi-experimental and qualitative study)
2. Settings: The study will take place at two sites: Mangochi District Hospital and Monkey Bay Community Hospital; Malawi.
3. sample size: Purposeful sampling and successive eligible patients. Sample size: Efficacy study will be conducted on 50 patients.
4. Intervention: brief behaviour change using 5A's and a Guiding style from motivational interviewing will be administered to participants in the intervention group by trained counsellors (nurses).

Eligibility criteria: 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

Primary outcomes:
measure: A measure of participants recruited (recruitment rate)
timeFrame: [Time frame: through study completion, an average of 24 weeks]
measure: Number participants who consented to take part in the study
timeFrame: [Time frame: through study completion, an average of 24 weeks]
measure: Proportion of participants who completed the study during the 12 weeks' period
timeFrame: [ time frame: up to 12 weeks]
measure: Proportion of participants who completed the study during the 24 weeks' period
timeFrame: [ Time frame: through study completion, an average of 24 weeks]
measure: Proportion of participants retained in the study
timeFrame: [ Time frame: through study completion, an average of 24 weeks]
measure: Proportions of participant's loss-to-follow-up at 12 weeks
timeFrame: [ time frame: up to 12 weeks]
measure: Loss-to-follow-up at 24 weeks
timeFrame: [ Time frame: through study completion, an average of 24 weeks]
Secondary outcomes:
measure: Change from baseline in Alcohol Use Disorder Identification Test-C at 12 weeks
timeFrame: [ Time frame: at baseline and in 12 weeks]
measure: Alcohol Use Disorder Identification Test-C at 24 weeks
timeFrame: [ Time frame: through study completion, an average of 24 weeks]
measure: 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
timeFrame: [ Time frame: at baseline and 24 weeks]
measure: Mean change in smoking from 12 weeks to 24 weeks using Short Fagerström Test for Nicotine dependence
timeFrame: [ Time frame: at 12 weeks and 24 weeks]
measure: 16. Change from 12 weeks in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
timeFrame: [Timeframe baseline, 12 weeks]
measure: Change from baseline in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)
timeFrame: [Timeframe: baseline and in 6 weeks]
measure: Change in theory of planned behavior constructs' scores from baseline to 12 weeks
timeFrame: [Timeframe: baseline, 12 weeks]
measure: Change in theory of planned behavior constructs' means' difference from 12 to 24 weeks
timeFrame: [Timeframe: 12 weeks through 24 weeks]
measure: To assess the change of the the theory of planned behavior constructs between baseline scores and 24 weeks'
timeFrame: [Time frame: 12, 24 weeks]
measure: Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the "Theoretical Model of Change" score
timeFrame: [time frame: baseline, 12 weeks]
measure: Change of TTT sub-scales means from 12 to 24 weeks in the "Theoretical Model of Change" scores
timeFrame: [Time frame: 12 weeks and 24 weeks]
Other outcomes:
measure: change from baseline in body weight at 12 weeks
timeFrame: [Time frame: baseline and 12 weeks]
measure: Change of body weight from 12 weeks at 24 weeks
timeFrame: [Time frame 12 and 24 weeks]
measure: Mean's change from baseline in Body Mass Index at 12 weeks
timeFrame: [Time Line: baseline and 12 weeks]
measure: Mean's Change from 12 weeks in Body Mass Index to 24 weeks
timeFrame: [Time Line: 12 weeks and 24 weeks]
measure: Means' Change from baseline in Body Mass Index to 24 weeks
timeFrame: [Time Frame: baseline and 24 weeks]
measure: Means' Change in waist -to- hip ratio at 12 weeks
timeFrame: [Time Line: baseline and 12 weeks]
measure: Mean's change in Mean waist-to-hip ratio (WHR) at 12 weeks
timeFrame: [ Time Frame: baseline and 12 weeks]
measure: Mean's change in Mean waist-to-hip ratio at 24 weeks
timeFrame: [ Time Frame: baseline and 24 weeks]
measure: Means' Change from baseline in pulse rate using an electronic blood pressure machine
timeFrame: [Time frame: baseline and 12 weeks]
measure: Means' change from 12 weeks in pulse rate using an electronic blood pressure machine
timeFrame: [Time frame: 12 and 24 weeks]
measure: 34. Means' change from baseline in the mean pulse rate to 24 weeks using an electronic blood pressure machine
timeFrame: [Time frame: baseline and 24 weeks]
measure: 35. Means' Change from baseline in the seated through cuff mean systolic blood pressure (SBP) from baseline to 12 weeks
timeFrame: [Time Frame: baseline and 12 weeks]
measure: Mean's change from 12 weeks in the seated patient through cuff mean systolic blood pressure from 12 to 24 weeks
timeFrame: [Time Frame: 12 weeks and 24 weeks]
measure: Mean's change from baseline in the seated through cuff mean systolic blood pressure (SBP) from baseline to 12 weeks
timeFrame: [Time Frame: baseline and 12 weeks]
measure: Mean's change from baseline in the seated patient through cuff mean systolic blood pressure from 0 to 24 weeks
timeFrame: [Time Frame: baseline and 24 weeks]
measure: Mean's change from baseline in the seated through cuff mean diastolic blood pressure (SBP) from baseline to 12 weeks
timeFrame: [Time Frame: baseline and 12 weeks]
measure: Mean's change from 12 weeks to 24 weeks in the seated patient through cuff mean diastolic blood pressure
timeFrame: [Time Frame: 12 weeks and 24 weeks]
measure: Means' change from baseline in the seated patient through cuff mean diastolic blood pressure from 0 to 24 weeks
timeFrame: [Time Frame: baseline and 24 weeks]
measure: Means' change from baseline in the level of fasting blood sugar (mg/dl)
timeFrame: [Time-line: baseline, 12 weeks]
measure: Means change from 12 weeks in the level of fasting blood sugar (mg/dl)
timeFrame: [Time-line: 12 weeks, 24 weeks]
measure: Means change from baseline in the level of fasting blood sugar (mg/dl)
timeFrame: [Time-line: 12 weeks, 24 weeks]
measure: Means change from baseline to 12 weeks in the level of total cholesterol (TC) (mg/dl)
timeFrame: [Time line: baseline, 12 weeks]
measure: Means change from 12 weeks to 24 in the level of total cholesterol (TC) (mg/dl)
timeFrame: [Time line: 12 weeks and 24 weeks]
measure: Means change from baseline to 24 weeks in the level of total cholesterol (TC) (mg/dl)
timeFrame: [Time line: baseline, 24 weeks]
measure: Means change from baseline to 12 weeks in the level of High density lipoproteins (HDL) (mg /dl)
timeFrame: [Time line: baseline, 12 weeks]
measure: Means change from 12 weeks to 24 in the level of High density lipoproteins (HDL) (mg/dl)
timeFrame: [Time line: 12 weeks and 24 weeks]
measure: Means change from baseline to 24 weeks in the level of High density lipoproteins (HDL) (mg/dl)
timeFrame: [Time line: baseline, 24 weeks]
measure: Means change from baseline to 12 weeks in the level of low density lipoproteins (LDL) (mg/dl)
timeFrame: [Time line: baseline, 12 weeks]
measure: Means change from 12 weeks to 24 in the level of low density lipoproteins (LDL) (mg/dl)
timeFrame: [Time line: 12 weeks and 24 weeks]
measure: Means change from baseline to 24 weeks in the level of Low density lipoproteins (LDL) (mg/dl)
timeFrame: [Time line: baseline, 24 weeks]
measure: Means change from baseline to 12 weeks in the level of triglycerides (TGC) (mg/dl)
timeFrame: [Time line: baseline, 12 weeks]
measure: Means change from 12 weeks to 24 in the level of triglycerides (TGC) (mg/dl)
timeFrame: [Time line: 12 weeks and 24 weeks]
measure: Means change from baseline to 24 weeks in the level of triglycerides (TGC) (mg/dl).
timeFrame: [Time line: baseline, 24 weeks]
Locations:
city: Mangochi
country: Malawi
facility: Mangochi District Hospital
state: Eastern-Region
Study officials:
affiliation: Kamuzu University of Health Sciences
name: Adamson S Muula, PhD
role: STUDY_DIRECTOR
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