Individual Study / EINSTEIN

Early Interventions to Support Trajectories for Healthy Life in India

Early Interventions to Support Trajectories for Healthy Life in India

EINSTEIN logo
Networks -
Datasets -
Variables -
Start Year
2020
End Year
2028
Supplementary Information
More information on the HeLTI consortium is available at https://helti.org/
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Members

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Investigators Contacts
  • Dr. Kalyanaraman Kumaran
    CSI Holdsworth Memorial Hospital
  • Dr. Kumar Gavali Suryanarayana
    Vivekananda Memorial Hospital
  • Dr. Stephen Matthews
    University of Toronto
  • Dr. Kalyanaraman Kumaran
    CSI Holdsworth Memorial Hospital
  • Dr. Ghattu V. Krishnaveni
    CSI Holdsworth Memorial Hospital

Design

Study design
Clinical trial
Follow Up
After the baseline preconception collection, mothers are are followed up 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 (10 to 17 weeks). After delivery, children are followed up five times postpartum (at 3, 6, 12, 36, and 60 months).

Marker Paper

Kumaran K, Krishnaveni GV, Suryanarayana KG et al. Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study. BMJ Open. 2021;11(2):e045862

PUBMED 33593789

Recruitment

Recruitment Target
  • Families

Number of Participants

Number of Participants
14,250
Number of Participants with Biological Samples
14,250
Supplementary Information

Mothers: 6000 participants

Fathers: 6000 participants

Children: 2250 participants

Access

Availability of data and biosamples

Possible Access to Data
Possible Access to Biosamples
Other

Timeline

Populations

Selection Criteria
Sex
Women
Minimum age
18
Maximum age
45
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
Ethnic Origin
Health Status
  • Only healthy volunteers were selected to participate in the study.
Other Criteria
Women are selected if they have no children or one child and are planning to have a child within the next 2 years.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants live in one of 35 villages cluster-randomized for the preconception intervention group.

Number of Participants

Number of Participants
2,000
Number of Participants with Biological Samples
2,000
Data Collection Events
# Name Description Start End
0 EINSTEIN - Mothers Preconception Intervention - Preconception Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
1 EINSTEIN - Mothers Preconception Intervention - Pregnancy 10 to 17 weeks Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
2 EINSTEIN - Mothers Preconception Intervention - Pregnancy 24 to 28 weeks Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
3 EINSTEIN - Mothers Preconception Intervention - Delivery Delivery details and any delivery complications such as ICU admissions, birth trauma, infections, and pre-eclampsia are collected. Information is also collected about adverse events (homicidal ... 2021 2023
5 EINSTEIN - Mothers Preconception Intervention - 3 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
6 EINSTEIN - Mothers Preconception Intervention - 6 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
7 EINSTEIN - Mothers Preconception Intervention - 12 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
8 EINSTEIN - Mothers Preconception Intervention - 24 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2023 2025
9 EINSTEIN - Mothers Preconception Intervention - 36 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2024 2026
10 EINSTEIN - Mothers Preconception Intervention - 60 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2026 2028
Selection Criteria
Sex
Women
Minimum age
18
Maximum age
45
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
Ethnic Origin
Health Status
  • Only healthy volunteers were selected to participate in the study.
Other Criteria
Women are selected if they have no children or one child and are planning to have a child within the next 2 years.
Supplementary Information about selection criteria

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants live in one of 35 villages cluster-randomized for the pregnancy intervention group.

Number of Participants

Number of Participants
2,000
Number of Participants with Biological Samples
2,000
Supplementary Information about selection criteria
Data Collection Events
# Name Description Start End
0 EINSTEIN - Mothers Pregnancy Intervention - Preconception Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
1 EINSTEIN - Mothers Pregnancy Intervention - Pregnancy 10 to 17 weeks Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
2 EINSTEIN - Mothers Pregnancy Intervention - Pregnancy 24 to 28 weeks Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
3 EINSTEIN - Mothers Pregnancy Intervention - Delivery Delivery details and any delivery complications such as ICU admissions, birth trauma, infections, and pre-eclampsia are collected. Information is also collected about adverse events (homicidal ... 2021 2023
5 EINSTEIN - Mothers Pregnancy Intervention - 3 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
6 EINSTEIN - Mothers Pregnancy Intervention - 6 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
7 EINSTEIN - Mothers Pregnancy Intervention - 12 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
8 EINSTEIN - Mothers Pregnancy Intervention - 24 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2023 2025
9 EINSTEIN - Mothers Pregnancy Intervention - 36 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2024 2026
10 EINSTEIN - Mothers Pregnancy Intervention - 60 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2026 2028
Selection Criteria
Sex
Women
Minimum age
18
Maximum age
45
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
Ethnic Origin
Health Status
  • Only healthy volunteers were selected to participate in the study.
Other Criteria
Women are selected if they have no children or one child and are planning to have a child within the next 2 years.

Recruitment

Sources of recruitment
  • General population
General Population
  • Volunteer enrolment
Supplementary Information
Participants live in one of 35 villages cluster-randomized for the pregnancy intervention group.

Number of Participants

Number of Participants
2,000
Number of Participants with Biological Samples
2,000
Data Collection Events
# Name Description Start End
0 EINSTEIN - Mothers Control - Preconception Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
1 EINSTEIN - Mothers Control - Pregnancy 10 to 17 weeks Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
2 EINSTEIN - Mothers Control - Pregnancy 24 to 28 weeks Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2021 2023
3 EINSTEIN - Mothers Control - Delivery Delivery details and any delivery complications such as ICU admissions, birth trauma, infections, and pre-eclampsia are collected. Information is also collected about adverse events (homicidal ... 2021 2023
5 EINSTEIN - Mothers Control - 3 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
6 EINSTEIN - Mothers Control - 6 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
7 EINSTEIN - Mothers Control -12 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2022 2024
8 EINSTEIN - Mothers Control - 24 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2023 2025
9 EINSTEIN - Mothers Control - 36 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2024 2026
10 EINSTEIN - Mothers Control - 60 months postpartum Information is collected about medical, treatment, and drug history, adverse events (homicidal behaviours, death, diseases), COVID-19 (symptoms, diagnosis, employment status), smoking and alcohol ... 2026 2028
Selection Criteria
Sex
Men
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
Ethnic Origin
Health Status
Other Criteria
Participants are excluded if pregnancy does not occur within 2 years from enrollment.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Other specific population : Fathers of participating children
Supplementary Information
Participants were recruited while recruiting participating women.

Number of Participants

Number of Participants
2,000
Number of Participants with Biological Samples
2,000
Data Collection Event
Start Date
2021
End Date
2023
Data sources
  • Questionnaires
  • Physical measures
  • Biosamples
Data sources - Biosamples
  • Blood
  • Saliva
Selection Criteria
Sex
Men
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
Ethnic Origin
Health Status
Other Criteria
Participants are excluded if pregnancy does not occur within 2 years from enrollment.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Other specific population : Fathers of participating children
Supplementary Information
Participants were recruited while recruiting participating women.

Number of Participants

Number of Participants
2,000
Number of Participants with Biological Samples
2,000
Data Collection Event
Start Date
2021
End Date
2023
Data sources
  • Questionnaires
  • Physical measures
  • Biosamples
Data sources - Biosamples
  • Blood
  • Saliva
Selection Criteria
Sex
Men
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
Ethnic Origin
Health Status
Other Criteria
Participants are excluded if pregnancy does not occur within 2 years from enrollment.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Other specific population : Fathers of participating children
Supplementary Information
Participants were recruited while recruiting participating women.

Number of Participants

Number of Participants
2,000
Number of Participants with Biological Samples
2,000
Data Collection Event
Start Date
2021
End Date
2023
Data sources
  • Questionnaires
  • Physical measures
  • Biosamples
Data sources - Biosamples
  • Blood
  • Saliva
Selection Criteria
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
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
750
Number of Participants with Biological Samples
750
Data Collection Events
# Name Description Start End
0 EINSTEIN - Children Preconception Intervention - Delivery Information is collected about feeding and breastfeeding, medical, treatment, and vaccination history, and adverse events (death and diseases). Head, arm, abdomen, and chest circumferences, ... 2021 2023
2 EINSTEIN - Children Preconception Intervention - 3 months postpartum Information is collected about feeding and breastfeeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), and ... 2022 2024
3 EINSTEIN - Children Preconception Intervention - 6 months postpartum Information is collected about feeding and breastfeeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), and ... 2022 2024
4 EINSTEIN - Children Preconception Intervention - 12 months postpartum Information is collected about diet, breastfeeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), screen time, and ... 2022 2024
5 EINSTEIN - Children Preconception Intervention - 24 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), diet, breastfeeding, screen time, ... 2023 2025
6 EINSTEIN - Children Preconception Intervention - 36 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), general health, diet, breastfeeding, and sleep. Executive function is measured ... 2024 2026
7 EINSTEIN - Children Preconception Intervention - 60 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), diet, breastfeeding, screen time, physical activity, general health, behaviour ... 2026 2028
Selection Criteria
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
Ethnic Origin
Health Status
Other Criteria

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Other specific population : Children of participating mothers.

Number of Participants

Number of Participants
750
Number of Participants with Biological Samples
750
Data Collection Events
# Name Description Start End
0 EINSTEIN - Children Pregnancy Intervention - Delivery Information is collected about feeding and breastfeeding, medical, treatment, and vaccination history, and adverse events (death and diseases). Head, arm, abdomen, and chest circumferences, ... 2021 2023
2 EINSTEIN - Children Pregnancy Intervention - 3 months postpartum Information is collected about feeding and breastfeeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), and ... 2022 2024
3 EINSTEIN - Children Pregnancy Intervention - 6 months postpartum Information is collected about feeding and breastfeeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), and ... 2022 2024
4 EINSTEIN - Children Pregnancy Intervention - 12 months postpartum Information is collected about diet, breastfeeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), screen time, and ... 2022 2024
5 EINSTEIN - Children Pregnancy Intervention - 24 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), diet, breastfeeding, screen time, ... 2023 2025
6 EINSTEIN - Children Pregnancy Intervention - 36 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), general health, diet, breastfeeding, and sleep. Executive function is measured ... 2024 2026
7 EINSTEIN - Children Pregnancy Intervention - 60 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), diet, breastfeeding, screen time, physical activity, general health, behaviour ... 2026 2028
Selection Criteria
Newborns
Twins
Countries
  • India
Territory
Saragur Taluks, Heggadadevanakote
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
750
Number of Participants with Biological Samples
750
Data Collection Events
# Name Description Start End
0 EINSTEIN - Children Control - Delivery Information is collected about feeding and breastfeeding, medical, treatment, and vaccination history, and adverse events (death and diseases). Head, arm, abdomen, and chest circumferences, ... 2021 2023
2 EINSTEIN - Children Control - 3 months postpartum Information is collected about feeding and breastfeeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), and ... 2022 2024
3 EINSTEIN - Children Control - 6 months postpartum Information is collected about feeding, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), and development (Ages and ... 2022 2024
4 EINSTEIN - Children Control - 12 months postpartum Information is collected about diet, breastfeedng, medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), screen time, and ... 2022 2024
5 EINSTEIN - Children Control - 24 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), sleep (Brief Infant Sleep Questionnaire), diet, breastfeedng, screen time, ... 2023 2025
6 EINSTEIN - Children Control - 36 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), general health, diet, breastfeedng, and sleep. Executive function is measured ... 2024 2026
7 EINSTEIN - Children Control - 60 months postpartum Information is collected about medical care, treatment and vaccination history, adverse events (death and diseases), diet, breastfeedng, screen time, physical activity, general health, behaviour ... 2026 2028

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
Social network
Social participation
Social support
Parenting and familial environment
Other social environment characteristics

Socio-demographic and economic characteristics

Age/birthdate
Sex/gender
Marital/partner status
Family and household structure
Education
Residence
Birthplace
Ethnicity, race and religion
Language
Labour force and retirement
Income, possessions, and benefits

Lifestyle and behaviours

Tobacco
Alcohol
Drugs
Nutrition
Breastfeeding
Physical activity
Sleep
Technological devices
Misbehaviour and criminality

Birth, pregnancy and reproductive health history

Puberty, menstruation, menopause and andropause
Pregnancy, delivery and birth

Perception of health, quality of life, development and functional limitations

Life course development

Diseases

Certain infectious and parasitic diseases (A00-B99)
Neoplasms (C00-D48)
Endocrine, nutritional and metabolic diseases (E00-E90)
Mental and behavioural disorders (F00-F99)
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)
Congenital malformations, deformations and chromosomal abnormalities (Q00-Q99)
External causes of morbidity and mortality (V01-Y98)
Diseases without precise specification or falling into multiple categories

Symptoms and signs

Symptoms and signs involving the circulatory and respiratory systems (R00-R09)
Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving cognition, perception, emotional state and behaviour (R40-R46)
General symptoms and signs (R50-R69)

Medication and supplements

Medication and supplement intake

Non-pharmacological interventions

Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions

Health and community care services utilization

Visits to health professionals
Hospitalizations
Community and social care

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

Preschool, school and work life

Preschool life

Social environment and relationships

Social support

Physical environment

Housing characteristics
Chemical exposure
Biological exposure

Administrative information

Identifiers
Date and time-related information
Questionnaire and interview-related information
Physical and cognitive measure and biosample-related information
Other administrative information

Personality

Early Childhood Behavior Questionnaire
General Self-Efficacy Scale
Strengths and Difficulties Questionnaire

Psychological distress and emotions

Edinburgh Postnatal Depression Scale
Goldberg Anxiety and Depression Scales (Anxiety)
Generalized Anxiety Disorder Scale
Perceived Stress Scale
Patient Health Questionnaire
PTSD Symptom Scale

Life events

Adverse Childhood Experiences Questionnaire

Life course development

Ages and Stages Questionnaire

Nutrition

24-hour Dietary Recall
Food Frequency Questionnaire (different forms)

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

Social support

Social Provisions Scale