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.: PACTR201903750173871 Date of Approval: 27/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bukhali: Building knowledge, optimising physical and mental health, and setting up healthier life trajectories in South African women
Official scientific title A preconception individually randomised controlled trial, part of the Healthy Life Trajectories Initiative (HeLTI)
Brief summary describing the background and objectives of the trial Does a integrated continuum of care intervention (4-phases) starting pre-conception and continued across the lifecourse (pregnancy, infancy and childhood) reduce childhood adiposity and the risk for NCDs, as well as improve measures of child development?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obesity,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 31/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1530
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bukhali 1 monthly one-on-one session with a community health worker, either delivered in person, or telephonically. 18 months, if no pregnancy. If participant becomes pregnant, the duration will be 60 months (to correspond with age of offspring). Individual (private) sessions: are designed to provide feedback to young women (for example, Hb status, nutritional status, blood pressure), offer services (home-based HIV and pregnancy testing), engage through Healthy Conversations to identify aspects of behaviour change, set goals and monitor, provide support to the family as needed and directed by the young women, and provide access to a healthcare referral network. Participants receive a resource book that was developed by topic experts and a specialised CHW curriculum developer, which integrate behaviour change theory and approach. A similar facilitator’s manual is available for the CHWs. The resource book and facilitator's manual cover 8 modules (women’s health, chronic diseases, diet, sleep, physical activity and fitness, sitting, body size and image, and emotional awareness) in 18 sessions. The resource book contains essential content, as well as space for participants to engage with the material through the use of checklists, diaries and reflections. For the pregnancy and postnatal period, the South African Department of Health Road to Health book provides the framework for the intervention, and the CHWs use a facilitator manual to guide their monthly contact sessions. In the infancy and early childhood period, participants receive a facilitator manual to guide monthly contact sessions, drawing on content to promote early childhood development and the prevention of early childhood obesity. Multi-micronutrient supplement: the CHW will dispense and monitor the micronutrient supplement use. The MMN supplement is based on WHO recommendations with 27mg of Fe. Participants that are determined to be anaemic will take daily supplements. Participants that have normal Hb levels will take the supplement twice a week. All participants will have their Hb concentrations assessed every 6months. The micronutrient breakdown is stipulated in the information sheet. 3000
Control Group Bukhali Call Centre 1 call per month, follow-up email or WhatsApp communication 18 months, if no pregnancy. If participant becomes pregnant, the duration will be 60 months (to correspond with age of offspring). Control arm (standard of care plus): materials are developed for a call centre intervention that covers practical life skills. Information will be provided via email, SMS and telephonic conversation. The call centre team will offer centre-based HIV and pregnancy testing and counselling. 3000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(i) women age 18-28 years at baseline measurement (i) women with type-I diabetes, cancer or epilepsy (ii) intellectual disability (iii) who are not able or willing to provide consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 28 Year(s) Female
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 02/02/2019 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown 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 23/06/2020 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown 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 03/12/2021 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown 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 06/12/2021 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child - Dual-energy X-ray absorptiometry-derived fat mass index (fat mass/height2) of the index-child at age 5 years 5 years old, index child
Secondary Outcome Child - Anthropometry (age- and sex-standardized continuous BMI-z score, BMI growth trajectories, continuous waist circumference z- score, upper arm circumference, head circumference) 5 years old, index child
Secondary Outcome Child - Cardiometabolic Outcomes: (systolic and diastolic blood pressure, lipid profile, glucose, insulin, insulin resistance) 5 years old, index child
Secondary Outcome Child - Health Behaviour Outcomes: dietary intake, physical activity, screen time, sedentary behaviour, sleep time 5 years old, index child
Secondary Outcome Child - Developmental and Mental Health Outcomes: cognitive, motor skills, communication, behavioural 5 years old, index child
Secondary Outcome Mother - Anthropometric Outcomes: overweight and obesity (OWO), DXA-derived body composition, waist circumference 2 years postpartum
Secondary Outcome Mother - Health Behaviour Outcomes: dietary patterns, physical activity, screen time, sedentary behaviour, sleep time, tobacco and alcohol use 2 years postpartum
Secondary Outcome Mother - Mental Health Outcomes: depressive symptoms, anxiety 2 years postpartum
Secondary Outcome Nutrition - aneamia 2 years postpartum
Secondary Outcome Physical health - hypertension 2 years postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
South African Medical Research Council Developmental Pathways for Health Research Unit University of the Witwatersrand Chris Hani Baragwanath Hospital, 26 Chris Hani Road, Soweto Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Francie van Zijl Drive, Parowvallei Cape Town 7505 South Africa
Canadian Institutes for Health Research 160 Elgin Street, 10th Floor Ottawa Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Developmental Pathways for Health Research Unit University of the Witwatersrand Chris Hani Baragwanath Hospital, 26 Chris Hani Road, Soweto Johannesburg 1864 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Professor Stephen Lye Lunenfeld-Tanenbaum Research Institute, Sinai Health System, Toronto and Departments of Obstetrics and Gynecology, Physiology and Medicine, University of Toronto Toronto Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shane Norris shane.norris@wits.ac.za +829282381 Chris Hani Baragwanath Hospital, 26 Chris Hani Road, Soweto
City Postal code Country Position/Affiliation
Johannesburg 1864 South Africa Research Professor and Director
Role Name Email Phone Street address
Public Enquiries Lisa Micklesfield lisa.micklesfield@wits.ac.za +27119331122 DPHRU, Wits Medical School, York Road
City Postal code Country Position/Affiliation
Johannesburg 2198 South Africa Associate Professor and Deputy Director
Role Name Email Phone Street address
Scientific Enquiries Catherine Draper catherine.draper@wits.ac.za +27119331122 DPHRU, Wits Medical School, York Road
City Postal code Country Position/Affiliation
Johannesburg 2198 South Africa Senior Researcher and Associate Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As the trial progresses through the four phases, data and samples will become available for analyses. Through the HeLTI Global Office in Toronto, data and biological sample requests from any or all of the trial sites can be made following the process as detailed on the HeLTI website. Informed Consent Form,Study Protocol Twelve months after the completion of each specific trial phase (Phase 1 2025; Phase 2 2026; Phase 3 2028; Phase 4 2031). Data will be made available upon reasonable request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://bmjopen.bmj.com/content/12/4/e059914 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