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Healthy Foundations Study: a randomised controlled trial to evaluate biological embedding of early-life experiences
Andrea Gonzalez1, Nicole Catherine2, Michael Boyle3
1Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.
Insights
The Nurse-Family Partnership (NFP) may reverse biological embedding of early adversity. This study examines NFP
Area of Science:
- Developmental psychology
- Genomic science
- Public health interventions
Background:
- Adverse early experiences can lead to long-term health and developmental issues.
- These experiences may become biologically embedded, increasing vulnerability.
- Preventive interventions' potential to reverse this embedding is understudied.
Purpose of the Study:
- To evaluate the impact of the Nurse-Family Partnership (NFP) on the biological outcomes of mothers and infants.
- To investigate the biological embedding of early adversity.
- To assess if NFP can mitigate these biological effects.
Main Methods:
- Birth cohort study recruiting pregnant mothers and newborns.
- Randomized controlled trial comparing NFP intervention with existing services.
- Collection of biological samples (hair, saliva, buccal swabs) for stress, immune function, and DNA methylation analysis.
- Follow-up to 2 years of child age, relating biological data to child outcomes.
Main Results:
- This study is pre-results; no findings are available yet.
Conclusions:
- Findings will inform stakeholders on how early adversity impacts health disparities.
- The study will provide insights into how early interventions like NFP may alter these disparities.
- Results will contribute to understanding the biological mechanisms linking early experiences to long-term health.
Introduction:
Adverse early experiences are associated with long-lasting disruptions in physiology, development and health. These experiences may be 'biologically embedded' into molecular and genomic systems that determine later expressions of vulnerability. Most studies to date have not examined whether preventive interventions can potentially reverse biological embedding. The Nurse-Family Partnership (NFP) is an evidence-based intervention with demonstrated efficacy in improving prenatal health, parenting and child functioning. The Healthy Foundations Study is an innovative birth cohort which will evaluate the impact of the NFP on biological outcomes of mothers and their infants.
Methods And Analysis:
Starting in 2013, up to 400 pregnant mothers and their newborns were recruited from the British Columbia Healthy Connections Project-a randomised controlled trial of the NFP, and will be followed to child aged 2 years. Women were recruited prior to 28 weeks' gestation and then individually randomised to receive existing services (comparison group) or NFP plus existing services (intervention group). Hair samples are collected from mothers at baseline and 2 months post partum to measure physiological stress. Saliva samples are collected from infants during all visits for analyses of stress and immune function. Buccal swabs are collected from infants at 2 and 24 months to assess DNA methylation. Biological samples will be related to child outcome measures at age 2 years.
Ethics And Dissemination:
The study received ethical approval from seven research ethics boards. Findings from this study will be shared broadly with the research community through peer-reviewed publications, and conference presentations, as well as seminars with our policy partners and relevant healthcare providers. The outcomes of this study will provide all stakeholders with important information regarding how early adversity may lead to health and behavioural disparities and how these may be altered through early interventions.
Trial Registration Number:
NCT01672060; Pre-results.
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