Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001228673
Ethics application status
Approved
Date submitted
27/09/2023
Date registered
29/11/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
29/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivering optimal weight gain guidance and support to pregnant women study
Scientific title
Delivering Optimal weighT gain advice to pregnant women (DOT): a case study to achieve healthy weight gain
Secondary ID [1] 310683 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DOT
Linked study record
We have conducted a pilot study and the Trial Id is: ACTRN12616001358437

Health condition
Health condition(s) or problem(s) studied:
Excess weight gain in pregnancy 331597 0
Condition category
Condition code
Reproductive Health and Childbirth 328331 328331 0 0
Antenatal care
Diet and Nutrition 328488 328488 0 0
Obesity
Metabolic and Endocrine 328489 328489 0 0
Diabetes
Public Health 328490 328490 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered during and as part of antenatal care. There will be one additional antenatal appointment and the duration of this appointment will be 30-45 minutes. There will be two further intervention sessions which can be either added to a usual antenatal appointment or be a separate appointment. Whether these two further intervention sessions are added to a usual antenatal appointment or are a separate appointment will depend on what is decided by the participant and her Lead Maternity Carer (LMC) midwife. These two further intervention sessions will each be about 15-30 minutes duration. The intervention appointments will take place at the place where the routine antenatal appointments occur, which is usually at the LMC midwife's practice rooms or the pregnant participant's home.

The first intervention visit will take place before 15 weeks gestation and this will be after the first registration antenatal visit. The intervention will consist of the LMC midwife asking some contextual lifestyle questions (see protocol) such as are there any dietary restrictions such as nut free or lactose free, how many people are in the household, who mostly purchase the household food, who mostly cooks household meals. There are also eight questions about eating habits using a modified validated questionnaire (STC:Diet). The response to these questions guides which part of the participant's eating habits to focus on and prompts further detailed questions to enable a goal setting process. Three realistic achievable lifestyle goals will be determined by the participant and her LMC midwife followed by a discussion as to how these could be achieved. Appropriate written resources will be provided or recommended by the LMC midwife.

The second intervention session will take place about 3-4 weeks after the first intervention appointment. The purpose of this second intervention session is to check on progress with achieving the lifestyle goals and revise or establish new goals as indicated, and to
provide further guidance and support.

The third intervention session will take place about 3-4 weeks after the second intervention session. The purpose of this third intervention session is the same as that for the second intervention visit.

The participating LMC midwives will attend a 5-hour training programme. The overarching goal of the training programme is to update skills and knowledge to enable the delivery of the intervention to enable healthy weight gain in pregnancy. There will be 1-hour of required pre-reading and self-reflection prior to attending a 2-hour training session via zoom. The topics in this zoom session will include the background to the study, a summary of the importance of healthy gestational weight gain, the principles of good food choice, an explanation of the intervention tool, including a brief dietary assessment and goal setting. This will be followed by a further 2-hour in person session, which will include a brief recap of the the intervention tool (brief dietary assessment and goal setting), an explanation and demonstration of the study processes including informed consent, data collection and recording and clinical measurements, followed by three case studies. The two 2-hour sessions will be delivered by the two study co-principle investigators and two dietitians working in the study area. The training materials are study specific.

It is intended that the training programme is delivered over a one month period, and that the the training programme is completed within 6-weeks of a participating LMC midwife enrolling her first pregnant participant into the study.

Adherence to the intervention by participants will be monitored by LMC midwives through assessment of goal achievement. Setting and progress with goal achievement will be recorded as part of data collection. Information at each of the three intervention visits such as answers to the brief dietary assessment, recording of participant goals and completion of clinical measures will be recorded electronically and reviewed monthly as part of routine data downloads for data checking. An Assistant Research Fellow will also communicate with participating LMC midwives regularly to support them with their study participation and implementation of the intervention.
Intervention code [1] 327090 0
Lifestyle
Comparator / control treatment
This is a case study. Therefore, there is no comparator / control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336182 0
Gestational weight gain from study entry to end of pregnancy
Timepoint [1] 336182 0
At each antenatal visit from study entry to end of pregnancy
Secondary outcome [1] 427228 0
Proportion of midwives who complete intervention training
Timepoint [1] 427228 0
Attendance recorded at the 2-hour zoom session and at the 2-hour in-person zoom session
Secondary outcome [2] 427229 0
Proportion of midwives who recruit at least 5 consecutive eligible women
Timepoint [2] 427229 0
At the end of the recruitment period
Secondary outcome [3] 427230 0
Proportion of invited women who decline to participate in the study
Timepoint [3] 427230 0
At the end of the recruitment period
Secondary outcome [4] 427231 0
Proportion of participating women who attend each of the three intervention visits (ANN1, ANN2 and ANN3)
Timepoint [4] 427231 0
End of pregnancy
Secondary outcome [5] 427232 0
Proportion of participating women who complete study to 6 week follow-up post birth.
Timepoint [5] 427232 0
6-weeks postnatal
Secondary outcome [6] 427233 0
Birthweight
Timepoint [6] 427233 0
At birth
Secondary outcome [7] 427234 0
Birthweight percentile
Timepoint [7] 427234 0
At birth

Eligibility
Key inclusion criteria
• Pregnant
• Antenatal registration with a Lead Maternity Carer midwife is in the first trimester before 15/40 and ideally before 10/40
• Able to communicate in English
• Planning to stay in the Northland / Te Tai Tokerau (Aotearoa New Zealand) area for the duration of the pregnancy and birth in Northland / Te Tai Tokerau (Aotearoa New Zealand)
• Aged 18 years or over
• First study (ANN1) visit is possible before 15/40
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pre-existing health condition requiring transfer of antenatal care to obstetric specialist care at booking as defined in the 2012 national guidelines*
• Pre-existing diabetes (any type)
• Health condition requiring specialist dietetic care e.g. coeliac disease, eating disorder

* Ministry of Health. 2012. Guidelines for Consultation with Obstetric and Related Medical Services (Referral Guidelines). Wellington: Ministry of Health.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Study aims and the planned statistical analysis for each
1. To determine whether the DOT intervention for achieving recommended maternal gestational weight gain (GWG) is acceptable to LMC midwives practising in Northland.
Outcome measures: Midwives who complete training, recruited at least 10 consecutive women
Statistical analyses:
i) Proportion of midwives who complete training, 95% confidence interval
ii) Proportion of midwives who recruit at least 10 consecutive eligible women, 95% CI

2. To determine whether the LMC midwife delivered DOT intervention for achieving recommended maternal gestational weight gain (GWG) is acceptable and accessible to pregnant women in Northland.
Outcome measures: accept/decline invitation to participate, completeness of intervention and follow-up.
Statistical analyses:
i) Proportion of invited women who decline to participate in the study, 95% CI
ii) Proportion of registered women who complete the intervention, proportions who complete ANN1, ANN2 ANN3, 95% CIs
iii) Proportion who complete study to 6 week follow-up post birth.

3. To describe the rate of gestational weight gain (GWG) and pregnancy outcomes, including birthweight for Northland women participating in the DOT intervention.
Outcome measures: Gestational weight gain (GWG) from study entry to end of pregnancy, birthweight, birthweight percentile
Statistical analysis: Distribution of rate of gestational weight gain, birthweight, birthweight percentile, descriptive statistics (LQ, median, UQ)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
27/03/2024
Date of last participant enrolment
Anticipated
24/01/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
175
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 25813 0
New Zealand
State/province [1] 25813 0
Northland (Te Tai Tokerau)

Funding & Sponsors
Funding source category [1] 314903 0
Government body
Name [1] 314903 0
Health Research Council of New Zealand
Country [1] 314903 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Main Campus Physical Address: 362 Leith Street, North Dunedin, Dunedin 9016; Postal Address: PO Box 56 Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 316910 0
None
Name [1] 316910 0
Address [1] 316910 0
Country [1] 316910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313896 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 313896 0
Ethics committee country [1] 313896 0
New Zealand
Date submitted for ethics approval [1] 313896 0
04/10/2023
Approval date [1] 313896 0
22/11/2023
Ethics approval number [1] 313896 0
2023 FULL 17956

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

Contacts
Principal investigator
Name 129710 0
A/Prof Kirsten Coppell
Address 129710 0
c/- Butterfly House, Nelson Hospital, Tipahi Street, Nelson South, NELSON 7010
Country 129710 0
New Zealand
Phone 129710 0
+64 21 279 1641
Fax 129710 0
Email 129710 0
[email protected]
Contact person for public queries
Name 129711 0
Kirsten Coppell
Address 129711 0
c/- Butterfly House, Nelson Hospital, Tipahi Street, Nelson South, NELSON 7010
Country 129711 0
New Zealand
Phone 129711 0
+64 21 279 1641
Fax 129711 0
Email 129711 0
[email protected]
Contact person for scientific queries
Name 129712 0
Kirsten Coppell
Address 129712 0
c/- Butterfly House, Nelson Hospital, Tipahi Street, Nelson South, NELSON 7010
Country 129712 0
New Zealand
Phone 129712 0
+64 21 279 1641
Fax 129712 0
Email 129712 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
De-identified data may be available in the future in Aotearoa New Zealand when formal guardianship and application processes are in place.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20491Ethical approvalEthics approval will be available when this has been received. [email protected]
20492Informed consent formThe informed consent form will be available when the study has received ethics approval. [email protected]



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.