The ORIGINS Project

Hagemann, E; Colvin, Lyn; Gibson, Lisa; Miller, Sarah J.; Palmer, Debra J.; Jois, Ravisha Srinivas; Silva, Desiree; Prescott, Susan L.

doi:10.1007/978-981-13-2194-8_6

Cited by 9 publications

(10 citation statements)

References 10 publications

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“…The BiBBS (Born in Bradford Better Start) Experimental Birth Cohort [ 7 ] aims to recruit 5000 pregnant mothers by 2024 in inner-city Bradford, North England, and to test over 20 interventions for children’s social and emotional development using a range of designs including Trials within Cohorts (TwiCs) and quasi-experimental designs. ORIGINS [ 12 ] aims to recruit 10,000 mothers in the Joondalup region (a community in northern Perth, Western Australia) between 2018 and 2023. Within this, active participants are invited to participate in Sub-projects if they meet the eligibility criteria, with participation in some projects restricted if the outcomes overlap; at time of writing, twelve nested randomized trials are currently under way (personal communication, J Davis).…”

Section: Discussionmentioning

confidence: 99%

“…One advantage is that the trial sample can be compared to a broader population in terms of baseline characteristics and natural history of a condition of interest and its short and long term outcomes. Trials may be conducted in parallel with the cohort and across a wide range of patient and participant groups, as in Western Australia’s ORIGINS Project [ 12 ]; with appropriate consent, a cohort may subsequently provide pre-randomization (e.g., genetic) and some or all outcomes data for trials. A second model has been variously labelled Zelen trials [ 13 ], cohort multiple randomized controlled trials (cmRCTs) [ 3 , 14 ], and Trials Within Cohorts (TWiCS), as in England’s Born in Bradford Better Start cohort [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

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Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Wake

Warren

et al. 2020

BMC Med Res Methodol

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Background Very large cohorts that span an entire population raise new prospects for the conduct of multiple trials that speed up advances in prevention or treatment while reducing participant, financial and regulatory burden. However, a review of literature reveals no blueprint to guide this systematically in practice. This Statement of Intent proposes how diverse trials may be integrated within or alongside Generation Victoria (GenV), a whole-of-state Australian birth cohort in planning, and delineates potential processes and opportunities. Methods Parents of all newborns (estimated 160,000) in the state of Victoria, Australia, will be approached for two full years from 2021. The cohort design comprises four elements: (1) consent soon after birth to follow the child and parent/s until study end or withdrawal; retrospective and prospective (2) linkage to clinical and administrative datasets and (3) banking of universal and clinical biosamples; and (4) GenV-collected biosamples and data. GenV-collected data will focus on overarching outcome and phenotypic measures using low-burden, universal-capable electronic interfaces, with funding-dependent face-to-face assessments tailored to universal settings during the early childhood, school and/or adult years. Results For population or registry-type trials within GenV, GenV will provide all outcomes data and consent via traditional, waiver, or Trials Within Cohorts models. Trials alongside GenV consent their own participants born within the GenV window; GenV may help identify potential participants via opt-in or opt-out expression of interest. Data sharing enriches trials with outcomes, prior data, and/or access to linked data contingent on custodian’s agreements, and supports modeling of causal effects to the population and between-trials comparisons of costs, benefits and utility. Data access will operate under the Findability, Accessibility, Interoperability, and Reusability (FAIR) and Care and Five Safes Principles. We consider governance, ethical and shared trial oversight, and expectations that trials will adhere to the best practice of the day. Conclusions Children and younger adults can access fewer trials than older adults. Integrating trials into mega-cohorts should improve health and well-being by generating faster, larger-scale evidence on a longer and/or broader horizon than previously possible. GenV will explore the limits and details of this approach over the coming years.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Wake

Warren

et al. 2020

BMC Med Res Methodol

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“…This study is a substudy of the ORIGINS project, a major Western Australian cohort study of 10 000 families who birth at Joondalup Health Campus, WA, a public/private secondary hospital in Perth’s northern suburbs. 42 43 The ORIGINS project is the largest representative sample of Australian infants in an observational cohort study, and includes a number of optional nested interventional studies. Early Moves will initiate recruitment through the ORIGINS project, before expanding to additional metropolitan secondary hospitals.…”

Section: Methodsmentioning

confidence: 99%

Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

et al. 2021

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IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

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“…ORIGINS is a longitudinal birth cohort study that recruits pregnant women and their partners from 12 weeks of gestational age and follows them and their child until 5 years postpartum. ORIGINS is open to any women who are birthing their baby at JHC [ 62 ]. Participants considered for inclusion in the MMM study will be women (1) at 18 to 30 weeks of pregnancy; (2) aged ≥18 years; (3) able to read, write, and understand English; and (4) able to access the internet.…”

Section: Methodsmentioning

confidence: 99%

“…If a participant reports concerns about their mental or physical health, this will be reported to ORIGINS. ORIGINS has standard operating procedures for following up adverse events [ 62 ]. All adverse events in the MMM study will be recorded on an adverse event monitoring form, and all events and follow-up will be reported to an independent study monitor.…”

Section: Methodsmentioning

confidence: 99%

Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial

Finlay‐Jones¹,

Davis²,

O'Donovan³

et al. 2020

JMIR Res Protoc

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Background Promoting psychological well-being and preventing distress among pregnant women is an important public health goal. In addition to adversely impacting the mother’s health and well-being, psychological distress in pregnancy increases the risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability in the postpartum period. Mindfulness and compassion-based interventions show potential for prevention and early intervention for perinatal distress. As there is an established need for accessible, scalable, flexible, and low-cost interventions, there is increased interest in the delivery of these programs on the web. This project aims to pilot a three-arm randomized controlled trial (RCT) to determine the feasibility of a full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation). Objective The primary objective of this study is to assess the feasibility of an RCT protocol comparing the 3 conditions delivered on the web as a series of instructional materials and brief daily practices over a course of 8 weeks. The second objective is to explore the experiences of women in the different intervention conditions. The third objective is to estimate SD values for the outcome measures to inform the design of an adequately powered trial to determine the comparative efficacy of the different conditions. Methods Pregnant women (n=75) participating in a longitudinal birth cohort study (the ORIGINS project) will be recruited to this study from 18 weeks of gestational age. We will assess the acceptability and feasibility of recruitment and retention strategies and the participants’ engagement and adherence to the interventions. We will also assess the experiences of women in each of the 3 intervention conditions by measuring weekly changes in their well-being and engagement with the program and by conducting a qualitative analysis of postprogram interviews. Results This project was funded in September 2019 and received ethics approval on July 8, 2020. Enrollment to the study will commence in September 2020. Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria. Conclusions If the study is shown to be feasible, results will be used to inform future full-scale RCTs. Evidence for flexible, scalable, and low-cost interventions could inform population health strategies to promote well-being and reduce psychological distress among pregnant women. Trial Registration Australian New Zealand Clinical Trials Registry Number 12620000672954p; http://anzctr.org.au/ACTRN12620000672954p.aspx International Registered Report Identifier (IRRID) PRR1-10.2196/19803

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The ORIGINS Project

Cited by 9 publications

References 10 publications

Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial

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