Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001053910
Ethics application status
Approved
Date submitted
8/07/2020
Date registered
15/10/2020
Date last updated
15/10/2020
Date data sharing statement initially provided
15/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising Health in Women across Pre-Pregnancy, Pregnancy & Post-Birth.
Scientific title
A randomised, healthy lifestyle intervention to optimise weight and weight related behaviours across preconception, pregnancy and postpartum: The OptimalMe Program
Secondary ID [1] 299108 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OptimalMe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reproductive Health 314157 0
Obesity 314158 0
Excess weight 318994 0
Gestational weight gain 318995 0
Condition category
Condition code
Public Health 312527 312527 0 0
Health promotion/education
Reproductive Health and Childbirth 312528 312528 0 0
Normal pregnancy
Reproductive Health and Childbirth 316963 316963 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315373 0
Lifestyle
Intervention code [2] 315374 0
Prevention
Intervention code [3] 315375 0
Behaviour
Comparator / control treatment
Receiving standard care only (standard treatment)
e.g. primary care via general practitioner
Control group
Active

Outcomes
Primary outcome [1] 321162 0
Program evaluation

Timepoint [1] 321162 0
Outcomes are conducted at the point of module entry and then repeated approximately 3 months later for both the pre-pregnancy and combined pregnancy/post-birth module to enable all intervention components to be delivered sufficiently as planned (i.e. module completion, two health coaching sessions, receipt of ongoing text messages). Outcomes are collected via mixed methods including quantitative (i.e. surveys at both time points with likert-scales and multiples choice options) and qualitative (i.e. semi-structured interviews at 3 months post study commencement).
Primary outcome [2] 324643 0
Evaluation of health literacy (Health literacy questionnaire, Osborne et al 2013) via surveys embedded in the program.
Timepoint [2] 324643 0
These outcomes are assessed at the point of module entry and then repeated approximately 3 months later for both the pre-pregnancy and combined pregnancy/post-birth module to enable all intervention components to be delivered sufficiently as planned (i.e. module completion, two health coaching sessions, receipt of ongoing text messages). Outcomes are measured in the form of online surveys embedded within the program (with likert-scales and multiples choice options) using sections 2, 4 and 9 from validated Health literacy questionnaire (Osborne et al 2013).
Primary outcome [3] 325152 0
Process evaluation (Fidelity)
Timepoint [3] 325152 0
Process evaluation of the health coaching sessions captured in real-time per participant during the pre-pregnancy component as well as the pregnancy component. Thus will be in the form of a short interview at the time of the session to capture progress and barriers in completed the module
Secondary outcome [1] 374145 0
Self-reported weight
Timepoint [1] 374145 0
This data will be entered by participants as part of the self-monitoring tools embedded into the program. There is no requirement on the frequency that they enter this information. Information that is entered is stored upon its creation. Data will be downloaded as a complete set following study completion as part of the program evaluation.
Secondary outcome [2] 385320 0
Pregnancy and birth outcome - Large-for-Gestational-Age (LGA)
Timepoint [2] 385320 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [3] 387010 0
Pregnancy and birth outcome - Small for gestational age (SGA)
Timepoint [3] 387010 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [4] 387012 0
Pregnancy and birth outcome - Disorders related to short gestation and low-birth weigh
Timepoint [4] 387012 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [5] 387013 0
Pregnancy and birth outcome - Gestational Diabetes Mellitus (GDM)
Timepoint [5] 387013 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [6] 387014 0
Pregnancy and birth outcome - Delivery method
Timepoint [6] 387014 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [7] 387015 0
Pregnancy and birthing outcome: - Neonatal intensive care unit (NICU) admission
Timepoint [7] 387015 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [8] 387016 0
IVF utilisation
Timepoint [8] 387016 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [9] 387017 0
Birth complications
Timepoint [9] 387017 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [10] 387018 0
Smoking rates
Timepoint [10] 387018 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [11] 387019 0
Chronic disease
Timepoint [11] 387019 0
Medibank Private passively collects hospital claims data as a by-product of paying hospital claims. As such, Medibank will collect pregnancy and birth outcomes of OptimalMe participants at the time of birth. Medibank will share health outcomes data linked to pregnancy and birth with Monash via a safe and secure platform (as per Medibank’s IT Security policy) at approximately three months following the OptimalMe participant’s birth claim. This will be also stated in the consent form at the time of enrolment to ensure informed consent.
Secondary outcome [12] 387020 0
Program engagement
Timepoint [12] 387020 0
This data comprises information on the frequency and duration of participant engagement within the program. This data will be downloaded as a complete set from the back-end analytics at the time of program completion.
Secondary outcome [13] 387021 0
Program reach
Timepoint [13] 387021 0
This will be calculated following the PIPE impact metric assessment of the penetration component of the program. This will be calculated at the time of program completion as a measure of Proportion of target population reached.
Secondary outcome [14] 387022 0
Dietary intake (Adherence to the Australian dietary guidelines)
Timepoint [14] 387022 0
Previously developed short form dietary questionnaire to capture adherence against the Australian Dietary Guidelines for women of reproductive age (reference below).
This outcome is assessed at the point of module entry and then repeated approximately 3 months later for both the pre-pregnancy and pregnancy module.
Reference:
Malek L, Umberger W, Makrides M, Zhou SJ. Adherence to the Australian dietary guidelines during pregnancy: evidence from a national study. Public Health Nutr. 2016;19(7):1155-1163. doi:10.1017/S1368980015002232

Eligibility
Key inclusion criteria
(i) Reproductive aged female members of Medibank Private Limited (MPL), aged between 18-44 years;
(ii) Have joined or upgraded their pre-existing membership cover to include pregnancy and
birth within the preceding 3 months;
(iii) Indicate pregnancy intention within 12 months;
(iv) Understand, read and speak English
(v) Access to a mobile phone / computer with internet access
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment to the mode of delivery of health coaching was based on a permuted block randomisation code.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
300
Accrual to date
112
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303643 0
Commercial sector/Industry
Name [1] 303643 0
Medibank Private
Country [1] 303643 0
Australia
Funding source category [2] 303645 0
University
Name [2] 303645 0
Monash University
Country [2] 303645 0
Australia
Primary sponsor type
Individual
Name
Dr. Cheryce Harrison
Address
Monash Centre for Health Research and Implementation
School of Public Health and Preventive Medicine,
Monash University, in partnership with Monash Health
Level 1, 43-51 Kanooka Grove, Clayton, Vic-3168
Country
Australia
Secondary sponsor category [1] 303734 0
Individual
Name [1] 303734 0
Prof. Helena Teede
Address [1] 303734 0
Monash Centre for Health Research and Implementation
School of Public Health and Preventive Medicine,
Monash University, in partnership with Monash Health
Level 1, 43-51 Kanooka Grove, Clayton, Vic-3168
Country [1] 303734 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304168 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 304168 0
Ethics committee country [1] 304168 0
Australia
Date submitted for ethics approval [1] 304168 0
Approval date [1] 304168 0
16/08/2019
Ethics approval number [1] 304168 0
RES-19-0000291A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96030 0
Dr Cheryce Harrison
Address 96030 0
Monash Centre for Health Research and Implementation
School of Public Health and Preventive Medicine,
Monash University, in partnership with Monash Health
Level 1, 43-51 Kanooka Grove
Clayton, VIC 3168
Country 96030 0
Australia
Phone 96030 0
+61423001543
Fax 96030 0
Email 96030 0
[email protected]
Contact person for public queries
Name 96031 0
Josphin Johnson
Address 96031 0
Monash Centre for Health Research and Implementation
School of Public Health and Preventive Medicine,
Monash University, in partnership with Monash Health
Level 1, 43-51 Kanooka Grove
Clayton, VIC 3168
Country 96031 0
Australia
Phone 96031 0
+61385722619
Fax 96031 0
Email 96031 0
[email protected]
Contact person for scientific queries
Name 96032 0
Cheryce Harrison
Address 96032 0
Monash Centre for Health Research and Implementation
School of Public Health and Preventive Medicine,
Monash University, in partnership with Monash Health
Level 1, 43-51 Kanooka Grove
Clayton, VIC 3168
Country 96032 0
Australia
Phone 96032 0
+61423001543
Fax 96032 0
Email 96032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.