BUilding Knowledge and a foundation for HeALthy lIfe trajectories
The objective of the study is to evaluate whether an intervention can optimize women's health before, during, and after pregnancy and reinforce optimal health in the child by counteracting obesity and cardiometabolic risk and improving cognitive development.
Overview
- Acronym
- BUKHALI
- Website
- BUKHALI
- Investigators
-
- Contacts
-
General Design
- Study design
- Clinical trial
- Start - End Year
- 2019 - 2029
- General Information on Follow Up (profile, frequency)
-
After the baseline preconception collection, mothers are followed up once at 18 months (if no pregnancy occurs) or twice during pregnancy (10 to 17 weeks and 24 to 28 weeks), once at delivery, and five times postpartum (at 3, 6, 12, 36, and 60 months). Fathers are only followed once at pregnancy (24 to 28 weeks). After delivery, children are followed up five times postpartum (at 3, 6, 12, 36, and 60 months).
- Recruitment Target
-
- Families
- Number of Participants
- 9,860
- Number of Participants with Biological Samples
- 9,860
- Supplementary information about number of participants
-
Mothers: 6800 participants
Fathers: 1530 participants
Children: 1530 participants
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Marker Papers
Norris SA, Draper CE, Prioreschi A, et al,. Building knowledge, optimising physical and mental health and setting up healthier life trajectories in South African women (Bukhali): a preconception randomised control trial part of the Healthy Life Trajectories Initiative (HeLTI). BMJ Open. 2022;12(4):e059914.
PUBMED 35450913Draper CE, Prioreschi A, Ware LJ, et al. Pilot implementation of Bukhali: A preconception health trial in South Africa. SAGE Open Med.;8:2050312120940542.
PUBMED 32685150Supplementary Information
More information on the HeLTI consortium is available at https://helti.org/
Timeline
Populations
BUKHALI - Mothers - Intervention
The population is composed of women 18 to 28 years old who live in the township of Soweto and are randomly allocated to the intervention group. In the intervention group, participants receive micronutrient supplements, resource material, individualized health feedback, free HIV and pregnancy testing, a specialized health curriculum, and discuss their challenges and priorities as young women living in Soweto and their perceptions of the intervention. To continue participating in this study, women must be pregnant within 18 months of enrollment.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
18
- Maximum age
-
28
- Countries
-
- South Africa
- Territory
- Soweto
- Health Status
-
- Women with type I diabetes, cancer, and/or epilepsy are excluded from this study.
- Other Criteria
- Women are excluded from this study if they have and intellectual disability or if they are not pregnant within 18 months of enrollment.
Sources of Recruitment
- Participants from Existing Studies
-
- Soweto Young Women’s Survey
- Supplementary Information
-
Participants are recruited if they completed the Soweto Young Women’s Survey.
Sample Size
- Number of Participants
- 3,400
- Number of Participants with Biological Samples
- 3,400
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | BUKHALI - Mothers Intervention - Preconception |
|
|
2019 (October) | 2022 (January) |
| 1 | BUKHALI - Mothers Intervention - Preconception 18 months |
|
|
2021 (May) | 2023 (July) |
| 2 | BUKHALI - Mothers Intervention - Pregnancy 10 to 17 weeks |
|
|
2020 (January) | 2023 (November) |
| 3 | BUKHALI - Mothers Intervention - Pregnancy 24 to 28 weeks |
|
|
2020 (March) | 2024 (February) |
| 4 | BUKHALI - Mothers Intervention - Delivery |
|
2020 (July) | 2024 (May) | |
| 7 | BUKHALI - Mothers Intervention - 6 months postpartum |
|
2021 (January) | 2024 (November) | |
| 8 | BUKHALI - Mothers Intervention - 12 months postpartum |
|
|
2021 (July) | 2025 (May) |
| 9 | BUKHALI - Mothers Intervention - 24 months postpartum |
|
|
2022 (July) | 2026 (May) |
| 11 | BUKHALI - Mothers Intervention - 60 months postpartum |
|
|
2025 (July) | 2029 (May) |
BUKHALI - Mothers - Control
The population is composed of women 18 to 28 years old who live in the township of Soweto and are randomly allocated to the control group of the study. In the control group, participants receive the standard of care plus a monthly curriculum on ‘life skills’ (not directly relating to health) via telephone, SMS and email and a monthly telephone call to discuss their challenges and priorities as young women living in Soweto. Participants also have access to free HIV and pregnancy testing and are advised to contact their local health facility for any other health concerns. To continue participating in this study, women must be pregnant within 18 months of enrollment.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
18
- Maximum age
-
28
- Countries
-
- South Africa
- Territory
- Soweto
- Health Status
-
- Women with type I diabetes, cancer, and/or epilepsy are excluded from this study.
- Other Criteria
- Women are excluded from this study if they have and intellectual disability or if they are not pregnant within 18 months of enrollment.
Sources of Recruitment
- Participants from Existing Studies
-
- Soweto Young Women’s Survey
- Supplementary Information
-
Participants are recruited if they completed the Soweto Young Women’s Survey.
Sample Size
- Number of Participants
- 3,400
- Number of Participants with Biological Samples
- 3,400
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | BUKHALI - Mothers Control - Preconception |
|
|
2019 (October) | 2022 (January) |
| 1 | BUKHALI - Mothers Control - Preconception 18 months |
|
|
2021 (May) | 2023 (July) |
| 2 | BUKHALI - Mothers Control - Pregnancy 10 to 17 weeks |
|
|
2020 (January) | 2023 (November) |
| 3 | BUKHALI - Mothers Control - Pregnancy 24 to 28 weeks |
|
|
2020 (March) | 2024 (February) |
| 4 | BUKHALI - Mothers Control - Delivery |
|
2020 (July) | 2024 (May) | |
| 7 | BUKHALI - Mothers Control - 6 months postpartum |
|
2021 (January) | 2024 (November) | |
| 8 | BUKHALI - Mothers Control - 12 months postpartum |
|
|
2021 (July) | 2025 (May) |
| 9 | BUKHALI - Mothers Control - 24 months postpartum |
|
|
2022 (July) | 2026 (May) |
| 11 | BUKHALI - Mothers Control - 60 months postpartum |
|
|
2025 (July) | 2029 (May) |
BUKHALI - Fathers - Intervention
The population is composed of the fathers of the child participants who are allocated to the intervention group.
Selection Criteria
- Gender
-
Men only
- Countries
-
- South Africa
- Territory
- Soweto
- Other Criteria
- Participants are excluded if pregnancy does not occur within 18 months of enrollment.
Sources of Recruitment
- Specific Population
-
- Other specific population : Fathers of participating children.
Sample Size
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | BUKHALI - Fathers Intervention - Pregnancy 24 to 28 weeks |
|
|
2020 (March) | 2024 (February) |
BUKHALI - Fathers - Control
The population is composed of the fathers of the child participants who are allocated to the control group of the study.
Selection Criteria
- Gender
-
Men only
- Countries
-
- South Africa
- Territory
- Soweto
- Other Criteria
- Participants are excluded if pregnancy does not occur within 18 months of enrollment.
Sources of Recruitment
- Specific Population
-
- Other specific population : Fathers of participating children.
Sample Size
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | BUKHALI - Fathers Control - Pregnancy 24 to 28 weeks |
|
|
2020 (March) | 2024 (February) |
BUKHALI - Children - Intervention
The population is composed of the children of participating mothers who are allocated to the intervention group.
Selection Criteria
- Newborns
- Countries
-
- South Africa
- Territory
- Soweto
Sources of Recruitment
- Specific Population
-
- Other specific population : Children of participating mothers.
Sample Size
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | BUKHALI - Children Intervention - Delivery |
|
2020 (July) | 2024 (May) | |
| 2 | BUKHALI - Children Intervention - 6 months postpartum |
|
2021 (January) | 2024 (November) | |
| 3 | BUKHALI - Children Intervention - 12 months postpartum |
|
|
2021 (July) | 2025 (May) |
| 4 | BUKHALI - Children Intervention - 24 months postpartum |
|
|
2022 (July) | 2026 (May) |
| 6 | BUKHALI - Children Intervention - 60 months postpartum |
|
|
2025 (July) | 2029 (May) |
BUKHALI - Children - Control
The population is composed of the children of participating mothers who are allocated to the control group.
Selection Criteria
- Newborns
- Countries
-
- South Africa
- Territory
- Soweto
Sources of Recruitment
- Specific Population
-
- Other specific population : Children of participating mothers.
Sample Size
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | BUKHALI - Children Control - Delivery |
|
2020 (July) | 2024 (May) | |
| 2 | BUKHALI - Children Control - 6 months postpartum |
|
2021 (January) | 2024 (November) | |
| 3 | BUKHALI - Children Control - 12 months postpartum |
|
|
2021 (July) | 2025 (May) |
| 4 | BUKHALI - Children Control - 24 months postpartum |
|
|
2022 (July) | 2026 (May) |
| 6 | BUKHALI - Children Control - 60 months postpartum |
|
|
2025 (July) | 2029 (May) |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2023-01-20T23:10:32.977