Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants
NCT ID: NCT04625452
Last Updated: 2020-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-08-13
2021-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
BBCC+5A's+GS
It is a 5-steps intervention delivered in a motivational interviewing spirit. Clearly the five steps are asking about the behaviour risk factors, assessing the level of risk factors; providing information about the pros and cons of the behaviour in a neutral way; assessing the change by probing about the importance in and the confidence of changing the risk factor; assisting the patient to come-up with a road map about changing the risk factor, connecting the patient to support networks or drugs which can increase the likelihood to change; and arranging for the next visit.
All this given by asking opened question to participant, active listening, summarizing what he is saying, evoking change through concepts or statements, empathy and asking permission to provide further information.
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)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BBCC+5A's+GS
It is a 5-steps intervention delivered in a motivational interviewing spirit. Clearly the five steps are asking about the behaviour risk factors, assessing the level of risk factors; providing information about the pros and cons of the behaviour in a neutral way; assessing the change by probing about the importance in and the confidence of changing the risk factor; assisting the patient to come-up with a road map about changing the risk factor, connecting the patient to support networks or drugs which can increase the likelihood to change; and arranging for the next visit.
All this given by asking opened question to participant, active listening, summarizing what he is saying, evoking change through concepts or statements, empathy and asking permission to provide further information.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* being pregnant
* patient with an active Psychiatrics' comorbidity
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Kamuzu University of Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adamson S Muula, PhD
Role: STUDY_DIRECTOR
Kamuzu University of Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mangochi District Hospital
Mangochi, Eastern-Region, Malawi
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
book website used for training of health workers in brief behavior change counseling in South Africa . Which we adopted for our study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P.08/18/2454
Identifier Type: -
Identifier Source: org_study_id