Early Interventions to Support Trajectories for Healthy Life in India
- Start Year
- 2020
- End Year
- 2028
- Supplementary Information
- More information on the HeLTI consortium is available at https://helti.org/
Visit EINSTEIN
| Investigators | Contacts |
|---|---|
|
|
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
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
Personality
Psychological distress and emotions
Life events
Life course development
Nutrition
Breastfeeding
Physical activity
Sleep