BUilding Knowledge and a foundation for HeALthy lIfe trajectories
Networks
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Datasets
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Variables
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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.
- Start Year
- 2019
- End Year
- 2029
- Supplementary Information
- More information on the HeLTI consortium is available at https://helti.org/
Visit BUKHALI
| Investigators | Contacts |
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Design
- Study design
- Clinical trial
- Follow Up
- 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).
Marker Paper
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 35450913
Recruitment
- Recruitment Target
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- Families
Number of Participants
- Number of Participants
- 9,860
- Number of Participants with Biological Samples
- 9,860
- Supplementary Information
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Mothers: 6800 participants
Fathers: 1530 participants
Children: 1530 participants
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
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
- Sex
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Women
- Minimum age
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18
- Maximum age
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28
- Newborns
- Twins
- Countries
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- South Africa
- Territory
- Soweto
- Ethnic Origin
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- Health Status
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- 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.
- Supplementary Information about selection criteria
Recruitment
- Sources of recruitment
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- Participants from existing studies
- Supplementary Information
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Participants are recruited if they completed the Soweto Young Women’s Survey.
- Participants from Existing Studies
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- Soweto Young Women’s Survey
Number of Participants
- Number of Participants
- 3,400
- Number of Participants with Biological Samples
- 3,400
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
BUKHALI - Mothers Intervention - Preconception
|
Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2019-10 | 2022-01 |
| 1 |
BUKHALI - Mothers Intervention - Preconception 18 months
|
Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2021-05 | 2023-07 |
| 2 |
BUKHALI - Mothers Intervention - Pregnancy 10 to 17 weeks
|
Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2020-01 | 2023-11 |
| 3 |
BUKHALI - Mothers Intervention - Pregnancy 24 to 28 weeks
|
Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2020-03 | 2024-02 |
| 4 |
BUKHALI - Mothers Intervention - Delivery
|
Information is collected about adverse events (homicidal behaviours, death, diseases) and COVID-19 (symptoms, diagnosis, employment status), the type of delivery, weight at delivery, the choice of ... | 2020-07 | 2024-05 |
| 7 |
BUKHALI - Mothers Intervention - 6 months postpartum
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Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2021-01 | 2024-11 |
| 8 |
BUKHALI - Mothers Intervention - 12 months postpartum
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Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2021-07 | 2025-05 |
| 9 |
BUKHALI - Mothers Intervention - 24 months postpartum
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Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2022-07 | 2026-05 |
| 11 |
BUKHALI - Mothers Intervention - 60 months postpartum
|
Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2025-07 | 2029-05 |
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
- Sex
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Women
- Minimum age
-
18
- Maximum age
-
28
- Newborns
- Twins
- Countries
-
- South Africa
- Territory
- Soweto
- Ethnic Origin
-
- 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.
Recruitment
- Sources of recruitment
-
- Participants from existing studies
- Supplementary Information
-
Participants are recruited if they completed the Soweto Young Women’s Survey.
- Participants from Existing Studies
-
- Soweto Young Women’s Survey
Number of Participants
- Number of Participants
- 3,400
- Number of Participants with Biological Samples
- 3,400
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
BUKHALI - Mothers Control - Preconception
|
Information is collected about the challenges and priorities for young women in Soweto, demographic details, general health, reproductive history, physical activity (Global Physical Activity ... | 2019-10 | 2022-01 |
| 1 |
BUKHALI - Mothers Control - Preconception 18 months
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Information is collected about the challenges and priorities for young women in Soweto, demographic details, general health, reproductive history, physical activity (Global Physical Activity ... | 2021-05 | 2023-07 |
| 2 |
BUKHALI - Mothers Control - Pregnancy 10 to 17 weeks
|
Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2020-01 | 2023-11 |
| 3 |
BUKHALI - Mothers Control - Pregnancy 24 to 28 weeks
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Information is collected about the challenges and priorities for young women in Soweto and the implementation challenges and perceptions of the intervention, demographic details, general health, ... | 2020-03 | 2024-02 |
| 4 |
BUKHALI - Mothers Control - Delivery
|
Information is collected about adverse events (homicidal behaviours, death, diseases) and COVID-19 (symptoms, diagnosis, employment status), the type of delivery, weight at delivery, the choice of ... | 2020-07 | 2024-05 |
| 7 |
BUKHALI - Mothers Control - 6 months postpartum
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Information is collected about the challenges and priorities for young women in Soweto, demographic details, general health, sedentary behaviours, diet, food security, sleep (Pittsburgh Sleep ... | 2021-01 | 2024-11 |
| 8 |
BUKHALI - Mothers Control - 12 months postpartum
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Information is collected about the challenges and priorities for young women in Soweto, demographic details, general health, physical activity (Global Physical Activity Questionnaire), sedentary ... | 2021-07 | 2025-05 |
| 9 |
BUKHALI - Mothers Control - 24 months postpartum
|
Information is collected about the challenges and priorities for young women in Soweto, demographic details, general health, physical activity (Global Physical Activity Questionnaire), sedentary ... | 2022-07 | 2026-05 |
| 11 |
BUKHALI - Mothers Control - 60 months postpartum
|
Information is collected about the challenges and priorities for young women in Soweto, demographic details, general health, physical activity (Global Physical Activity Questionnaire), sedentary ... | 2025-07 | 2029-05 |
The population is composed of the fathers of the child participants who are allocated to the intervention group.
Selection Criteria
- Sex
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Men
- Newborns
- Twins
- Countries
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- South Africa
- Territory
- Soweto
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Participants are excluded if pregnancy does not occur within 18 months of enrollment.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : Fathers of participating children.
Number of Participants
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Event
Information is collected about socio-demographic characteristics, medical history, COVID-19 (diagnosis), physical activity (Global Physical Activity Questionnaire) and sitting time, tobacco, alcohol, and drug use (WHO-STEPS, AUDIT-Questionnaire), diet and food security, sleep (Pittsburgh Sleep Quality Index), general self-efficacy (General Self-Efficacy Scale), anxiety, and depression (Patient Health Questionnaire-9).
Height, weight, mid-upper arm and waist circumferences, and blood pressure measurements are collected.
Blood and urine samples are collected from a subset of the population.
- Start Date
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2020-03
- End Date
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2024-02
- Data sources
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- Questionnaires
- Physical measures
- Biosamples
- Data sources - Biosamples
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- Blood
- Urine
The population is composed of the fathers of the child participants who are allocated to the control group of the study.
Selection Criteria
- Sex
-
Men
- Newborns
- Twins
- Countries
-
- South Africa
- Territory
- Soweto
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Participants are excluded if pregnancy does not occur within 18 months of enrollment.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : Fathers of participating children.
Number of Participants
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Event
Information is collected about socio-demographic characteristics, medical history, COVID-19 (diagnosis), physical activity (Global Physical Activity Questionnaire) and sitting time, tobacco, alcohol, and drug use (WHO-STEPS, AUDIT-Questionnaire), diet and food security, sleep (Pittsburgh Sleep Quality Index), general self-efficacy (General Self-Efficacy Scale), anxiety, and depression (Patient Health Questionnaire-9).
Height, weight, mid-upper arm and waist circumferences, and blood pressure measurements are collected.
Blood and urine samples are collected from a subset of the population.
- Start Date
-
2020-03
- End Date
-
2024-02
- Data sources
-
- Questionnaires
- Physical measures
- Biosamples
- Data sources - Biosamples
-
- Blood
- Urine
The population is composed of the children of participating mothers who are allocated to the intervention group.
Selection Criteria
- Newborns
- Twins
- Countries
-
- South Africa
- Territory
- Soweto
- Ethnic Origin
-
- Health Status
-
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : Children of participating mothers.
Number of Participants
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
BUKHALI - Children Intervention - Delivery
|
Information is collected about adverse events (death and diseases), date of birth, sex, gestational age and fetal growth, APGAR scores, and birth complications (such as hospitalizations, birth ... | 2020-07 | 2024-05 |
| 2 |
BUKHALI - Children Intervention - 6 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, screen time, sleep (Brief Infant Sleep Questionnaire), development (Ages and Stages Questionnaire version 3), ... | 2021-01 | 2024-11 |
| 3 |
BUKHALI - Children Intervention - 12 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, physical activity, screen time, sleep (Brief Infant Sleep Questionnaire), development (Ages and Stages Questionnaire ... | 2021-07 | 2025-05 |
| 4 |
BUKHALI - Children Intervention - 24 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, physical activity, screen time, sleep (Brief Infant Sleep Questionnaire), development (Ages and Stages Questionnaire ... | 2022-07 | 2026-05 |
| 6 |
BUKHALI - Children Intervention - 60 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, physical activity, screen time, sleep (SUNRISE sleep questionnaire), development (Ages and Stages Questionnaire ... | 2025-07 | 2029-05 |
The population is composed of the children of participating mothers who are allocated to the control group.
Selection Criteria
- Newborns
- Twins
- Countries
-
- South Africa
- Territory
- Soweto
- Ethnic Origin
-
- Health Status
-
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : Children of participating mothers.
Number of Participants
- Number of Participants
- 765
- Number of Participants with Biological Samples
- 765
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
BUKHALI - Children Control - Delivery
|
Information is collected about adverse events (death and diseases), date of birth, sex, gestational age and fetal growth, APGAR scores, and birth complications (such as hospitalizations, birth ... | 2020-07 | 2024-05 |
| 2 |
BUKHALI - Children Control - 6 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, screen time, sleep (Brief Infant Sleep Questionnaire), development (Ages and Stages Questionnaire version 3), ... | 2021-01 | 2024-11 |
| 3 |
BUKHALI - Children Control - 12 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, physical activity, screen time, sleep (Brief Infant Sleep Questionnaire), development (Ages and Stages Questionnaire ... | 2021-07 | 2025-05 |
| 4 |
BUKHALI - Children Control - 24 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, physical activity, screen time, sleep (Brief Infant Sleep Questionnaire), development (Ages and Stages Questionnaire ... | 2022-07 | 2026-05 |
| 6 |
BUKHALI - Children Control - 60 months postpartum
|
Information is collected about development, growth, nutrition, breastfeeding, physical activity, screen time, sleep (SUNRISE sleep questionnaire), development (Ages and Stages Questionnaire ... | 2025-07 | 2029-05 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
- Cognitive functioning
- Personality
- Psychological distress and emotions
- Other psychological measures and assessments
- Life events
- Beliefs and values
- Perception of health
- Quality of life
- Life course development
- Functional limitations
- Other perception of health, quality of life and functional limitation-related information
- Tobacco
- Alcohol
- Drugs
- Nutrition
- Breastfeeding
- Physical activity
- Sleep
- Sexual behaviours and orientation
- Technological devices
- Misbehaviour and criminality
- Other and unspecified lifestyle information
Socio-demographic and economic characteristics
Age/birthdate
Sex/gender
Marital/partner status
Family and household structure
Education
Residence
Birthplace
Language
Labour force and retirement
Income, possessions, and benefits
Other socio-demographic and economic characteristics
Lifestyle and behaviours
Tobacco
Alcohol
Drugs
Nutrition
Breastfeeding
Physical activity
Sleep
Technological devices
Birth, pregnancy and reproductive health history
Puberty, menstruation, menopause and andropause
Contraception
Pregnancy, delivery and birth
Perception of health, quality of life, development and functional limitations
Perception of health
Life course development
Diseases
Certain infectious and parasitic diseases (A00-B99)
Neoplasms (C00-D48)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D50-D89)
Endocrine, nutritional and metabolic diseases (E00-E90)
Mental and behavioural disorders (F00-F99)
Diseases of the nervous system (G00-G99)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the genitourinary system (N00-N99)
Pregnancy, childbirth and the puerperium (O00-O9A)
Certain conditions originating in the perinatal period (P00-P96)
Injury, poisoning and certain other consequences of external causes (S00-T98)
Diseases without precise specification or falling into multiple categories
Symptoms and signs
Symptoms and signs involving the digestive system and abdomen (R10-R19)
Medication and supplements
Medication and supplement intake
Non-pharmacological interventions
Surgical interventions
Educational and health promotion interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions
Health and community care services utilization
Visits to health professionals
Hospitalizations
Death
Vital status
Cause of death
Physical measures and assessments
Anthropometry
Circulation and respiration
Muscles, skeleton and mobility
Skin and subcutaneous tissue
Other physical measures and assessments
Laboratory measures
Hematology
Biochemistry
Virology
Cognition, personality and psychological measures and assessments
Personality
Psychological distress and emotions
Life events, life plans, beliefs and values
Life events
Beliefs and values
Preschool, school and work life
Preschool life
Work life
Social environment and relationships
Social network
Social participation
Social support
Parenting and familial environment
Physical environment
Housing characteristics
Built environment/neighbourhood characteristics
Chemical exposure
Other physical environment characteristics
Administrative information
Identifiers
Date and time-related information
Questionnaire and interview-related information
Physical and cognitive measure and biosample-related information
Data and sample collection center-related information
Other administrative information
Personality
General Self-Efficacy Scale
Strengths and Difficulties Questionnaire
Psychological distress and emotions
Edinburgh Postnatal Depression Scale
Generalized Anxiety Disorder Scale
Perceived Stress Scale
Patient Health Questionnaire
Life events
Adverse Childhood Experiences Questionnaire
Life course development
Affordances in the Home Environment for Motor Development - Infant Scale
Ages and Stages Questionnaire
Global Scale for Early Development
Alcohol
Alcohol Use Disorders Identification Test
Breastfeeding
Breastfeeding Self-Efficacy Scale
Physical activity
Global Physical Activity Questionnaire
Screen time-based sedentary behaviour questionnaire
Sleep
Brief Infant Sleep Questionnaire
Pittsburgh Sleep Quality Index