Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401595576921 Date of Approval: 11/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of motivational interview on salt intake among patients with hypertension in Nigeria
Official scientific title Effect of motivational interview initiative on salt intake among adult patients with hypertension attending the Family Medicine Clinic of University College Hospital, Ibadan, Nigeria – A Randomised Control Trial
Brief summary describing the background and objectives of the trial Background Hypertension is a disease of public health importance with higher prevalence in Low and Middle-Income Countries. It is the leading single cause of morbidity and mortality worldwide and a growing public health problem in sub-Saharan Africa (SSA). Motivational interviewing (MI) is a person-centred counselling approach that is based on the three fundamental components of Collaboration, Evocation, and Autonomy aimed at effecting behavioural change by helping clients explore and resolve ambivalence. This study seeks to determine the effect of Motivational Interview on salt intake among patients with hypertension in Nigeria. Methods The study will employ a randomized controlled trial of 156 adults with Hypertension in Nigeria over six months. Systematic random sampling will be utilized for recruitment and randomization of participants into the intervention and control group. The intervention group will get a motivational interview on Salt intake in addition to standard care for hypertension while the control group receives the standard care for the management of hypertension only. Data Analysis Data will be analysed using the Statistical Package for Social Sciences window version 20 (SPSS 20) software package and Total Diet Assessment (TDA) Software. Expected Outcome The study anticipates a salt intake reduction, Blood Pressure reduction rates (≥10mmHg), and BP Control (<140/90mmHg) in the intervention group compared with the control group. This will be assessed at baseline and six months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EMIS
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 31/07/2024
Anticipated target sample size (number of participants) 156
Actual target sample size (number of participants) 160
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Motivational Interviewing techniques Monthly Six months The intervention of the study consisted of Motivational Interview Sessions about salt consumption and blood pressure control to be held monthly for the intervention group. MI is based on the three fundamental components of Collaboration, Evocation, and Autonomy and principles like empathy, supporting self-efficacy, reflective listening, summarising, developing discrepancy, and rolling with resistance. Using MI principles has proved useful in addressing many behavioural health issues. 78
Control Group Motivational Interviewing Monthly Six Months The intervention group will get a motivational interview on salt intake in addition to standard care for hypertension. While the control group receives standard care for the management of hypertension only. 78 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria 1. Adult patients aged 18 years and above. 2. Patients with hypertension (Systolic BP ≥ 140mmHg and Diastolic BP ≥ 90mm Hg) 3. Patients with no plan of migrating out of the community within the next six months. Exclusion Criteria 1. Physical or mental disability that would impair cognition. 2. Severely ill or weak patients whose condition would not allow them to be interviewed at review dates. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/10/2023 University of Ibadan University College Hospital Ibadan Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Queens Elizabeth Drive Ibadan 202202 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary study outcomes will be salt intake reduction in the intervention arm compared with the control arm. This will be assessed at baseline and six months.
Secondary Outcome Secondary study outcomes will be reduced blood pressure in the intervention arm compared to the control arm. This will be assessed at baseline and six months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Family Medicine Clinic University College Hospital Ibadan Nigeria Queens Elizabeth Drive Ibadan 202202 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
African Research Universities Alliance ARUA Centre of Excellence for NonCommunicable Diseases University of Nairobi Main Campus Gandhi Wing 5th Floor Nairobi Kenya Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ARUA Centre of Excellence for NCDs University of Nairobi Main Campus, Gandhi Wing 5th Floor Nairobi Kenya Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Temitope Ilori tilori@com.ui.edu.ng +2348023009099 Community Medicine Department University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 202000 Nigeria Senior Lecturer Consultant Family Physician
Role Name Email Phone Street address
Public Enquiries Tijani OSENI tijanioseni@yahoo.com 08036281897 Dept. of Family Medicine
City Postal code Country Position/Affiliation
Irrua Nigeria Medical Doctor
Role Name Email Phone Street address
Scientific Enquiries Tawakalit Olubukola Salam deotab@yahoo.com +2348034436746 Department of Family Medicine University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant Family Physician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes My participants will receive communications on the research findings. Their clinical data and investigation results will be communicated through telephone calls and follow-ups. Strict confidentiality will be ensured, and data will be encrypted and protected from third parties. Informed Consent Form,Statistical Analysis Plan,Study Protocol Two years 2024 -2026 Controlled data access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information