RecruitingACTRN12620001053910

Optimising Health in Women across Pre-Pregnancy, Pregnancy & Post-Birth.

A randomised, healthy lifestyle intervention to optimise weight and weight related behaviours across preconception, pregnancy and postpartum: The OptimalMe Program


Sponsor

Dr. Cheryce Harrison

Enrollment

300 participants

Start Date

Jul 1, 2020

Study Type

Interventional

Conditions

Summary

Overweight/obesity is a National Health Priority and women of reproductive age are at greatest risk with a high rate of weight gain and increasing proportions entering pregnancy overweight (>30%) or obese (20%). Once pregnant, 60% have excessive gestational weight gain (GWG) and 65% retain weight postpartum. Simple lifestyle interventions can prevent weight gain and related complications for improved health. Here we aim to adapt and diversify an evidence based lifestyle intervention to optimise healthy weight and modifiable lifestyle behaviours across preconception, pregnancy and postpartum life stages. Utilising a novel design we will recruit women preconception that have signalled pregnancy intention by joining or upgrading their private health insurance to include Obstetrics cover via our funding partner Medibank Private. Women will receive 3 healthy lifestyle modules across preconception, pregnancy and postpartum, delivered via an online platform with ongoing support provided. Outcomes will include improved preconception health knowledge and risk perception, optimised weight gain in pregnancy and limited postpartum weight retention.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 44 Yearss

Plain Language Summary

Simplified for easier understanding

This study supports women of reproductive age in achieving a healthy weight and lifestyle before, during, and after pregnancy. Entering pregnancy with overweight or obesity is increasingly common in Australia, and it raises the risk of complications for both mother and baby. Many women also gain more weight than recommended during pregnancy and struggle to lose it afterwards. This program, delivered through an online platform, offers three personalised healthy lifestyle modules — one focused on the period before conception, one during pregnancy, and one after birth. The goal is to help women understand their health risks, manage weight gain during pregnancy, and avoid holding onto excess weight afterwards. Support is provided throughout the program to help participants stay on track. You may be eligible if you are a female Medibank Private member aged 18 to 44 who has recently joined or upgraded to obstetrics cover, intends to become pregnant within the next 12 months, can read and understand English, and has access to a mobile phone or computer with internet. There are no exclusion criteria — all women meeting the above are welcome.

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

Description of intervention(s) / exposure: OptimalMe is a pragmatic, randomised controlled trial delivered to women with private healthcare (Medibank Private Ltd) that have recently upgraded or joined

Description of intervention(s) / exposure: OptimalMe is a pragmatic, randomised controlled trial delivered to women with private healthcare (Medibank Private Ltd) that have recently upgraded or joined with pregnancy and birth cover. The intervention comprises a healthy lifestyle program, OptimalMe involving three components delivered prior to pregnancy (Pre-pregnancy), during pregnancy (Pregnancy) and post-birth (Post-birth). The program is delivered individually, online, in the form of 3 interactive and personalised modules that focus on simple and effective healthy lifestyle messages. Women are recruited prior to pregnancy (Pre-pregnancy) and are followed during preconception, during pregnancy and are given information for the post-birth period (Post-birth). Modules have been developed explicitly for this program and have been designed to accessed in succession according to each relevant life-phase. Modules are personalised with information provided to participants tailored according to a set of standard screening questions related to their preconception and pregnancy health. Healthy lifestyle information is accompanied with behavioural change components, underpinned by the Social Cognitive Theory including goal planning, problem solving, self-monitoring and relapse prevention. These components are practised through a series of interactive activities delivered in the online platform. Each module follows a similar format of relevant information according to reproductive phase and behaviour change and self-monitoring tools. Each module takes approximately 45 minutes to complete, however is designed to be iteratively accessed at any time during each phase (i.e. pre-pregnancy, pregnancy and post-birth). When women preconception become pregnant, they enter the next module (i.e. pregnancy) by entering their estimate due date, enabling access. Access is only made available on entering an estimated due date and is ultimately controlled by the participant. The estimate due date is used to automatically enable access to the post-birth module from approximately 20-week gestation. This is to ensure the pregnancy module is accessed first and additionally, to reduce participant burden with information received. In addition to the OptimalMe program, participants are randomised to receive health coaching delivered via telephone or video conference. Health coaching will reiterate program messages, encourage compliance and practice behavioural skills delivered within the platform. Health coaching will be delivered twice in pre-pregnancy at 2-4 weeks and 6-8 weeks post study commencement and twice during pregnancy in the first and second trimester. Health coaching will be delivered by health professionals with qualifications in nutrition, dietetics and exercise physiology. Participants are considered to have completed the study when they have completed all relevant modules in order of succession- Pre-pregnancy, Pregnancy, Post-birth, and completed all associated questionnaires and program evaluation up to and including 36 weeks gestation. Women will remain in the intervention with support provided for up to 2 years, irrespective of pregnancy outcome. Following two years, women will be provided with access to the online platform (funding permitting), but will not receive ongoing support.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12620001053910


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