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.: PACTR202306662753321 Date of Approval: 29/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Feasibility and acceptability of a contextualized physical activity and diet intervention for the control of hypertension in adults from a rural sub-district: the HYPERTENSION study.
Official scientific title Feasibility and acceptability of a contextualized physical activity and diet intervention for the control of hypertension in adults from a rural sub-district: a non-randomised feasibility study (HYPERTENSION).
Brief summary describing the background and objectives of the trial In rural and remote South Africa, most strokes and ischaemic heart diseases are because of hypertension, which is a controllable risk factor. The widely recommended therapeutic approaches to control hypertension are through physical activity and diet modifications. However, there is a lack of culturally sensitive community-based, lifestyle interventions to control hypertension among rural African adult populations. We designed an intervention which recommends adjusting daily routine physical activity and dietary behaviour of adults with hypertension. This study aims to evaluate the feasibility and acceptability of HYPERTENSION in a rural community setting.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied hypertension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/05/2023
Actual trial start date 02/05/2023
Anticipated date of last follow up 28/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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
Single Group Non-randomised 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 HYPERTENSION Ten weeks The intervention will comprise of three components: a structured group education session consisting of up to 10 participants per session, an individualized physical activity education, and an individualized dietary education. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 40 years and older. Self-reported diagnosis of hypertension or currently on medication for hypertension. Lived in the district study setting for minimum six months prior to start of intervention. Participants who are dependant Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 100 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 08/06/2021 University of the Witwatersrand Human Research Ethics Committee medical
Ethics Committee Address
Street address City Postal code Country
7 york road Johannesburg 2193 South Africa
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 24/08/2021 Mpumalanga PHRC
Ethics Committee Address
Street address City Postal code Country
Indwe Building, Government Boulevard, Riverside Park, Ext. 2 Mbombela 1200 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -Recruitment rate -Intervention uptake -Reasons for refusal -Completion rate -Follow up rate -Acceptability interview -Fidelity -Adherence rate baseline, during intervention, and at 10 weeks follow-up
Secondary Outcome -Blood pressure -BMI (height and weight) -Waist-Hip Ratio (WHR) -Urine sample collection -Nutrition questionnaire– 24HR diet recall -Accelerometer physical activity baseline and end of intervention at 10 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agincourt HDSS Agincourt village Bushbuckridge 1368 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
CARTA APHRC campus, Manga close Nairobi 10787-001 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self primary investigator 7 york road johannesburg 2193 South Africa principal investigator
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kganetso Sekome kganetso.sekome@wits.ac.za 0117173705 7 york road
City Postal code Country Position/Affiliation
parktown 2193 South Africa Lecturer
Role Name Email Phone Street address
Public Enquiries Kganetso Sekome kganetso.sekome@wits.ac.za +27117173705 7 york road
City Postal code Country Position/Affiliation
parktown 2193 South Africa Lecturer
Role Name Email Phone Street address
Scientific Enquiries Kganetso Sekome kganetso.sekome@wits.ac.za +27117173705 7 york road
City Postal code Country Position/Affiliation
parktown 2193 South Africa Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants in this trial will be assigned a number for de-identification. As per confidentiality and ethical standards guidelines, participant identities will not be shared publicly. Only the research team will have access to the participant's identifying data. Study Protocol By December 2024 public repository
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.wiredspace.wits.ac.za 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