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.: PACTR202404603482748 Date of Approval: 17/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Transtheoretical-model-based Education on Cardiovascular Risks and Quality of Life among Persons with Hypertension
Official scientific title Effect of Transtheoretical-model-based Education on Transtheoretical-model Components, Physical Activity Behaviour, Blood Pressure, Quality of Life, and Adiposity Indices among Individuals with Hypertension
Brief summary describing the background and objectives of the trial Despite the well-established benefits of physical activity (PA) for managing hypertension and adiposity, many individuals with hypertension do not engage in sufficient levels of physical activity (Lee, et al., 2022). While it is important to find ways of helping persons with hypertension start and maintain a lifestyle of optimal PA levels, attempts at this may achieve more by focusing on increasing the PA levels and behaviours of such individuals rather than prescribing strict exercise regimens. The Transtheoretical model (TTM) has been proven beneficial in improving PA participation among different individual groups and populations. Some studies have suggested that TTM-based education programs may be effective in promoting PA and improving health outcomes among individuals with hypertension. However, more research is needed to fully understand the impact of these programs on behaviour change and health outcomes. This study is designed to adapt and validate the TTM variables cross-culturally, to tailor the use of TTM specifically to PA behaviours of individuals of the Igbo culture living with hypertension and to determine the efficacy of the TTM in fostering and maintaining healthy PA levels among the presence living with hypertension in Nnewi, Anambra State Nigeria This study will be a randomized control trial with a sample size of 150 at an effect size of 0.4. The result of this study will produce psychometrically sound, culturally and environmentally appropriate Instruments for assessing exercise decisional balance, exercise process of change, exercise self-efficacy, and temptation not to exercise among persons living with hypertension in Nnewi. In all, through the reported synergistic/additive effect of PA on the effect of antihypertensive drugs, the outcome of this study is expected to improve the management of hypertension such that adequate BP control is achieved in more individuals at a lower drug dose. Understanding the impact of TTM-based education on the
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/03/2024
Actual trial start date 01/03/2024
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transtheoretical model based educational modules 12weeks Intervention group 1: Participants for this phase shall be consecutively recruited from the selected clinics and hospitals (the MOP, GOPD and NHIS clinics of the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Heritage Specialist Clinic, Mercy Specialist Hospital, and Accu-care Hospital, Nnewi), but randomly assigned to either the control or the intervention group using a random number generator. The intervention group shall be persons living with Hypertension (PLWH) who will be on antihypertensive drugs and also undergo the TTM-based health education programme. In achieving this, the SoC for the participants in the intervention group shall be determined. Then the RPOCS will be used to determine the appropriate health education contents for the SoC of a participant. Information on socio-demographic variables including age, gender, educational level, marital status, and occupation will be collected. In addition, information on TTM variables (PA stage of change, process of change, PA self-efficacy, perceived PA benefits, perceived barriers to PA, and Temptation not to engage in PA), QoL, PA level, adiposity indices (BMI, WC, WHR), and BP will be collected on all participants at baseline and after 12 weeks. 75
Control Group Hypertension medication 12weeks Control group 2: The control group shall be PLWH who will be on anti-hypertensive agents only, 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults (18 years and above) with hypertension in Nnewi North L.G.A, who give their informed consent and who have no mobility-related impairments shall be recruited for the study. 1. Women within six months post-partum period who have pregnancy-induced hypertension (which may still be unresolved) shall be excluded from the study. 2. Pregnant women with hypertension 3. Individuals with secondary hypertension 4. Breast-feeding women 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 10/10/2023 Nnamdi Azikiwe University Teaching Hospital Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
PMB 5025, Awka, Anambra State Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Physical Activity Stage of Change Interview Instrument will be used to determine the participants’ PA SoC. b. Revised Exercise Processes of Change Scale will be used to determine the appropriate intervention for each participant based on his PA SoC. c. Revised Decisional Balance Scale will be used to determine participants’ perceived benefits and barriers to PA. d. Exercise Self-efficacy Scale shall be used for assessing participants’ level of confidence in their ability to perform PA. d. Temptation not to Exercise Scale shall be used to determine temptation not to exercise. e. Automated Blood Pressure Monitor will be used to measure participants’ blood pressure at intervals f. Digital Bathroom Scale will be used for measuring participants’ body weight g. Wooden Height Meter will be used to measure participants’ height h. Elastic Non-stretch Tape Measure will be used to measure participants’ waist and hip circumferences. h. Mobile Video Recording App shall be used for making guide and Instruction videos for Participants i. The 12-item Health Survey (SF-12) shall be used to measure participants’ quality of life. j. The Short-form International Physical Activity Questionnaire IPAQ-SF shall be used to assess the PA level of participants. At the beginning, weekly intervals during the trial and at the end of the 12weeks of intervention
Secondary Outcome PA behaviours and Body mass index At the beginning, weekly intervals during the trial and at the end of the 12weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Onitsha Old Road Nnewi Onitsha Old Road 435101 Nigeria
Heritage specialist clinic Nnewi Nnewi 435101 Nigeria
Mercy specialist hospital Nnewi Nnewi Nigeria
Accucare hospital Nnewi Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self Nnewi Nnewi Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nnamdi Azikiwe University Nnewi Nnewi Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeoma Amaechi ia.amaechi@unizik.edu.ng +2348063328692 Medical Rehabilitation department, College of Health Sciences, Okofia
City Postal code Country Position/Affiliation
Nnewi Nigeria Nnamdi Azikiwe University
Role Name Email Phone Street address
Public Enquiries Uchechukwu Chukwuemeka muecj@yahoo.com +2348072107228 Medical Rehabilitation department, College of Health Sciences, Okofia
City Postal code Country Position/Affiliation
Nnewi Nigeria Nnamdi Azikiwe University
Role Name Email Phone Street address
Scientific Enquiries Ifeoma Amaechi ia.amaechi@unizik.edu.ng +2348063328692 Medical Rehabilitation department, College of Health Sciences, Okofia
City Postal code Country Position/Affiliation
Nnewi Nigeria Nnamdi Azikiwe University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlies the results reported in the articles after de-identifications shall be available on reasonable request Clinical Study Report,Informed Consent Form,Statistical Analysis Plan 12months Needed for educational and research pruposes
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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlies the results reported in the articles after de-identifications shall be available on reasonable request Clinical Study Report,Informed Consent Form,Statistical Analysis Plan 12months Needed for educational and research pruposes
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