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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- A measure of participants recruited (recruitment rate)
Study Overview
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
-
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The data will be collected under investigator's supervision, documented by nurses ( counselors), clinical officers ( doing routine consultations), lab technicians ( analyzing blood) and the clerk doing the measurements. Data sent to the investigators and statisticians for entry and analysis will be blinded beforehand by removing the identifiers' information. After completing the analysis, results will be again allocated to their respective arms.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: BBCC+5A's+GS (Behavioral)
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)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change from baseline in Alcohol Use Disorder Identification Test-C at 12 weeks([ Time frame: at baseline and in 12 weeks])
- Alcohol Use Disorder Identification Test-C at 24 weeks([ 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: at baseline and 24 weeks])
- Mean change in smoking from 12 weeks to 24 weeks using Short Fagerström Test for Nicotine dependence([ 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)([Timeframe baseline, 12 weeks])
- Change from baseline in health-related quality of life using the World Health Organization quality of life tool (WHOQOL-Bref)([Timeframe: baseline and in 6 weeks])
- Change in theory of planned behavior constructs' scores from baseline to 12 weeks([Timeframe: baseline, 12 weeks])
- Change in theory of planned behavior constructs' means' difference from 12 to 24 weeks([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: 12, 24 weeks])
- Change of Trans theoretical model (TTM) stage from baseline to 12 weeks in the "Theoretical Model of Change" score([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: 12 weeks and 24 weeks])