HeLTI - Mothers - Preconception Harmonization Protocol
The objective of the Preconception Harmonization Protocol was to define a list of core variables prospectively to be collected by the four mother and child randomized controlled trials to address the research aims of the HeLTI Initiative.
Overview
- Harmonization Initiative
- HeLTI-HI
- Harmonization Protocol
- HeLTI-M-PC-HP
- Version
- 1.0
- Number of Variables
Design
- Type
- Quantitative
- Approach
- Prospective
- Procedures
- Harmonized data is generated locally by studies (with the collaboration of the harmonization team).
- Infrastructure
- Harmonized data must remain on study servers, but federated data analysis can be achieved
- Participant Inclusion
- HeLTI participating mothers from the four studies
Information Content
The HeLTI Preconception harmonized dataset includes information about:
- Socio-demographic and economic characteristics (age and sex, household composition, education level, country of birth, employment status)
- Lifestyle and behaviours (alcohol use, tobacco use, drug use, diet and nutrition, Pittsburgh Sleep Quality Index (PSQI) and Global Physical Activity Questionnaire (GPAQ))
- Reproductive health history (number of pregnancies, number of abortions or miscarriages)
- Diseases
- Medication
- Adverse events (hospitalization, disability/incapacity, assault, homicidal behaviour, life-threatening conditions)
- COVID-19 (risk factors, symptoms, testing, diagnosis, self-isolation)
- Physical measures and assessments (height and weight, BMI, blood pressure)
- Laboratory measurements (blood sample)
- Cognitive measures and assessments (General Self-Efficacy Scale (GSE), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7))
- Life events (Adverse Childhood Experiences Questionnaire (ACE))
- Administrative information
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Harmonization
Scroll over each status icon to get more details on the corresponding harmonization results:
- Complete - study-specific variable is the same as DataSchema variable (status detail = identical) or needs transformation to generate DataSchema variable (status detail = compatible) or unknown (status detail = unknown)
- Partial - categorical study-specific variable (status detail = proximate) or other types (status detail = tentative) could generate DataSchema variable but with loss of information or unknown (status detail = unknown)
- Impossible - study does not collect DataSchema variable (status detail = unavailable) or cannot be used to generate DataSchema variable (status detail = incompatible) or unknown (status detail = unknown)
- Not Applicable - harmonization status is not relevant
- Undetermined - harmonization status not determined
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per Dataset
No Areas of Information Collected
No Scales Collected
Last Update: 2023-06-05T09:03:30.266