RecruitingACTRN12617001599369

The Raine Study: A multi-generational, life-course study of health and well-being from before birth through to adulthood.

The Raine Study: A multi-generational life-course study utilising rich genetic, phenotypic (cardiometabolic, respiratory, immunological, musculoskeletal, psychological, hormonal, reproductive, vision, hearing), behavioural (sleep, activity, diet, risky behaviour), environmental (chemical, spatial, social) and education and work data to improve human health and well-being.


Sponsor

University of Western Australia

Enrollment

5,000 participants

Start Date

May 18, 1989

Study Type

Observational

Conditions

Summary

In 1989 Professor John Newnham and colleagues invited more than 3000 pregnant women to join a National Health and Medical Research Council funded research study at King Edward Memorial Hospital to examine the possible beneficial effects of repeated fetal ultrasound imaging studies. Women were allocated at random into one of two groups – Regular Care or Intensive Care. Those in the Regular Care group had a single ultrasound imaging study at 18 weeks gestation, with further scans only if clinically indicated. The women in the Intensive Care group had ultrasound scans at 18, 24, 28, 34 and 38 weeks gestation. Along with Professor Newnham, a group of prominent investigators (Professor Fiona Stanley, Professor Lou Landau and Professor Con Michael) formed a group to establish these families into a cohort study, focusing on the child, to determine how events during pregnancy and childhood influence health in later life. This was initially supported with funding from the Raine Medical Research Foundation. The original cohort of 2868 children (Generation 2), is one of the largest, most successful prospective cohorts of pregnancy, childhood, adolescence and now adulthood to be carried out anywhere in the world. This cohort has provided environmental, developmental and health information over the past 27 years providing a unique and valuable resource covering a wide range of health areas. Follow-up assessment of the cohort has been conducted at birth, 1, 2, 3, 5, 8, 10, 14, 17, 18, 20, 22, 27 and currently 33 years of age by a collaborative team of researchers from The University of Western Australia, Women and Infants Research Foundation, Telethon Kids Institute, Curtin University, Edith Cowan University, the University of Notre Dame, Murdoch University, the Lions Eye Institute, and many other national and international collaborators. The original parents (Generation 1) participated in the assessments as well, providing information about their children and about themselves. Generation 1 has recently participated in assessments of sleep, obesity and activity. In addition, the off-spring (Generation 3) of the original cohort (Generation 2) are currently being recruited and participating in assessments of developmental ability and physical activity. The other (non Raine Study) parent of the Gen 3 participant is also being recruited (Gen 2B).


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

The Raine Study is a long-running research project that has been following thousands of families in Western Australia since 1989 — from pregnancy through to adulthood — to understand how events early in life shape health later on. Now it is also following the children and grandchildren of the original participants. You may be eligible if: - You are part of the original Raine Study (Generation 1 or 2), OR - You are a biological child of a Generation 2 participant (Generation 3), OR - You are the other parent of a Generation 3 child (Generation 2B), OR - You are a grandparent of the original cohort (Generation 0) You may NOT be eligible if: - You are Generation 1 and your pregnancy did not result in a live birth Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Four Generations are currently involved in the Raine Study: Generation 1 - women (and their partners) presenting to King Edward Memorial Hospital and surrounding private clinics in Perth, Western A

Four Generations are currently involved in the Raine Study: Generation 1 - women (and their partners) presenting to King Edward Memorial Hospital and surrounding private clinics in Perth, Western Australia who were between 16 and 20 weeks pregnant. 2,900 women were recruited between May 1989 and November 1991. In 2017 average age was 56 years (range 40-80). Assessments may continue every 3-5 years until death. Enrolment for Generation 1 participants is closed; they can choose to participate in any / all follow-up assessments. Generation 2 - live born children of the Generation 1 women (n=2868), These were born between August 1989 and May 1992, thus in 2023 average age is 33. Assessments are intended to continue every 3 years until death. Enrolment of Generation 2 participants are closed; they can choose to participate in any / all follow-up assessments. Generation 3 - live born children of Generation 2 women and men. As the Generation 3 children will be born over several decades, follow-up assessments may occur every 3-5 years rather than at specific ages. Enrolment of Gen 3 participants is ongoing, as they are born. The intention is to follow this generation until death also. Generation 2B - the other biological parent of the Generation 3 participant. The intention is to collect information on Gen 2B parents every 3-5 years. Due to Gen 3 enrolment being ongoing, the enrolment of Gen2B is ongoing also. Generation 0 - grandparents of Generation 2. Intention is to capture data on as many of this generation as possible before they are no longer able to participate in data collection. Life-course exposures are being assessed. For Generation 1 - exposures have been assessed at 18 and 36 weeks pregnancy, birth of their child, and when their child was 1, 2, 3, 5, 8, 10, 14, 17, and 26 years of age. Exposures are currently being assessed as part of the Generations follow-up (age of child is 33 years). The intention is to follow Generation 1 until death. Behaviour exposures including sleep, activity (physical activity, sedentary behaviour), diet (diet, dietary behaviour), risky behaviour (drug use - alcohol, tobacco, other drugs, driving). Environment exposures, including chemical (for example hormones and endocrine disruptors) and medical exposures, such as ultrasounds and anaesthesia. Built and social environment including type of housing, neighbourhood and family relationships, and work. For Generation 2 - exposures have been assessed at 18 and 36 weeks gestation, birth, and 1, 2, 3, 5, 8, 10, 14, 17, 20, 22, 27 and 28 years of age. The current 33 year follow-up commenced in 2023. The intention is to regularly assess them until death. Behaviour exposures including sleep, activity (physical activity, sedentary behaviour, technology use), diet (diet, dietary behaviour, breastfed), risky behaviour (drug use - alcohol, tobacco, other drugs, sexual behaviour, driving). Environment exposures including perinatal exposures such as obstetric factors; maternal nutrition, maternal exercise, maternal drugs (medications, smoking, alcohol, illicit), maternal stress and maternal mental health; chemical (such as endocrine disrupters and other pollutants), noise and sunlight exposure and medical procedure exposures (such as ultrasounds and anaesthesia). Built and social environment including neighbourhood security, parks, walkability, shops, fast food outlets, and family relationships, peer relationships, work colleague relationships. For Generation 3 - exposures are being assessed at ages ranging between 0 and 18 years. The intention is to regularly assess all Generation 3 every 3-5 years. Behaviour exposures including physical activity and diet. Environment exposures such as chemical exposures (including hormones and gut bacteria) and medical exposures. Social exposures, including family relationships and cognition. For Generation 2B - medical history, sociodemographic, phenotypic, behavioural and environmental exposure data is being collected. For Generation 0 - sociodemographic, medical history, phenotypic data, behavioural exposure and environmental exposure data is being collected (approximately 100 Gen0 participants to date).


Locations(1)

King Edward Memorial Hospital - Subiaco

WA, Australia

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ACTRN12617001599369