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.: PACTR202211567803436 Date of Approval: 01/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Building healthier communities
Official scientific title Building healthier communities: vulnerability, informal settlements and health
Brief summary describing the background and objectives of the trial The literature shows that environmental health - and specifically, exposure to air pollution and environmental pathogens - can affect child nourishment, growth and specifically stunting. Our study will assess the contribution of air pollution and environmental pathogens on the likelihood of stunting by following approximately 1000 households in the Eastern Cape and Western Cape as they move from a shack to a subsidised formal house. We focus on children under five because children are particularly vulnerable during these early years and because this development period has been shown to be so decisive for outcomes later in life. We will collect detailed information about the living conditions, access to services, mental health and dietary intake of these households, and collect biometric information for children under 5 and their mothers. We will administer a lightweight and affordable set of complementary mid-line interventions designed to unlock the latent value and benefits of the government’s large investment in formal housing. The first package intervention combines the nutrition intervention with an air quality intervention that lowers the effective cost of using electricity for heating and cooking. The second package intervention combines the nutrition intervention with a gut health intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations,Mental and Behavioural Disorders,Nutritional, Metabolic, Endocrine,Oral Health,Paediatrics,Pregnancy and Childbirth,Respiratory
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Package intervention
Anticipated trial start date 03/11/2022
Actual trial start date
Anticipated date of last follow up 31/07/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1240
Actual target sample size (number of participants)
Recruitment status Not yet 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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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
Control Group No intervention 6-12 months No intervention 790 Uncontrolled
Experimental Group Package intervention 1 6-12 months The first package intervention combines the nutrition intervention with an air quality intervention that lowers the effective cost of using electricity for heating and cooking. 150
Experimental Group Package intervention 2 6-12 months The second package intervention combines the nutrition intervention with a gut health intervention. 150
Experimental Group Package intervention 1 and 2 6-12 months It is a combination of the first and second package intervention, thus combining the nutrition intervention with an air quality intervention and a gut health intervention. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Household of approved beneficiary for selected building project Includes either one child under 5 or a pregnant female Mother cannot be under 18 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 99 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 01/09/2022 Stellenbosch University Health Research Ethics Committee 1
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Avenue (Tygerberg) Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Height for age Baseline and endline, and for intensive sample at more regular intervals
Secondary Outcome Gut health measures, air pollution PM2.5 Baseline and end-line, and more regularly for intensive subsample
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
De Hoop building project Kiewiet Street Malmesbury South Africa
Greenville building project Baobab Rd Cape Town South Africa
Transhex building site Ngxangosi street Worcester South Africa
Joe Slovo and Khanaymnandi building sites Melumzi street Gqeberha South Africa
Cenyulands and Cenyu village RDP building projects Spring Rd Stutterheim South Africa
Nyganga Mema street Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF Meiring Naude Road Pretoria South Africa
SAMRC Francie Van Zijl Drive Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ronelle Burger Bosman Street Stellenbosch South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Marisa von Fintel Bosman Street Stellenbosch South Africa
Dumisani Hompashe 1 King Williamstown Rd Alice South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ronelle Burger rburger@sun.ac.za 0218083106 Bosman Street
City Postal code Country Position/Affiliation
Stellenbosch South Africa Professor Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Ronelle Burger rburger@sun.ac.za 0218083106 Bosman Street
City Postal code Country Position/Affiliation
Stellenbosch University South Africa Professor Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Ronelle Burger rburger@sun.ac.za 0218083106 Bosman Street
City Postal code Country Position/Affiliation
Stellenbosch South Africa Professor Stellenbosch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share our results 9 months after article publication on a per request basis and for a 24 month window. We will make the data publicly available after 3 years. Informed Consent Form We will share our results 9 months after article publication on a per request basis and for a 24 month window. We will make the data publicly available after 3 years. Open
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