Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001358437
Ethics application status
Approved
Date submitted
23/09/2016
Date registered
29/09/2016
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Date results information initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivering Optimal weight gain advice To pregnant women study.
Scientific title
Delivering structured nutrition advice to pregnant women to achieve healthy weight gain in pregnancy: A feasibility study
Secondary ID [1] 289497 0
Nil
Universal Trial Number (UTN)
Trial acronym
DOT - Delivering Optimal weight gain advice To pregnant women study.
Linked study record
This study is related to the Prediabetes Intervention Package in Primary Care Study (Trial ID: ACTRN 12615000806561). The only difference is that the dietary advice will be delivered by midwives (not practice nurses) and modified to take into account the food safety restrictions for pregnant women.

Health condition
Health condition(s) or problem(s) studied:
Excess weight gain in pregnancy 299195 0
Condition category
Condition code
Diet and Nutrition 299204 299204 0 0
Obesity
Reproductive Health and Childbirth 300275 300275 0 0
Antenatal care
Public Health 300276 300276 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a feasibility study. It seeks to determine the feasisbility of a Lead Maternity Carer (LMC) midwife delivering a structured dietary intervention to achieve recommended healthy weight gain during pregnancy for the wellbeing of the mother and the development and growth of the foetus. In this feasibility study we will examine the actual time required to comfortably deliver the structured weight management intervention, how best to collect and collate data from the maternity consultations and obtain data to inform sample size calculations for the main trial. We will recruit 8 midwives who will each recruit 3-5 women with a singleton pregnancy at <15 weeks gestation. Midwives will be trained to deliver the structured dietary intervention as part of antenatal care. The training will involve attending a 6 hour workshop delivered by the researchers (public health physician, obstetrician, midwife, nurse and dietitian). The topics covered in the workshop will include the study rationale, nutrition principles and food label reading, familiarisation with the structured dietary advice approach and case studies. The dietary advice will be based on the New Zealand recommendations in the Ministry of Health 'Guidance for Healthy Weight Gain in Pregnancy 2014'. Participating pregnant women will be invited to attend up to 3 additional antenatal appointments before 22 weeks gestation for specific nutritional advice. The first nutrition in pregnancy appointment will be ideally at 10 weeks gestation, but before 15 weeks gestation. This appointment will be 30-45 minutes during which time a dietary assessment will be conducted, 2-3 dietary goals established and appropriate individualised dieary advice given. The dietary advice will be individualised for each woman taking into account their sociocultural context, food likes and dislikes, household budgets and household membership, The second and third nutrition in pregnancy appoinments will be 15-30 minutes, and will be either 'stand alone' separate appointments or an additional component of routine anetnatal care appointments. The second appointment will be 3-4 weeks after the first appointment, ideally be at 14 weeks gestation, but before 18 weeks. The third appointment will be 3-4 weeks after the second appointment, ideally be at 18 weeks duration, but before 22 weeks. The appointments will be conducted at either the LMC midwife's clinic or the participating pregnant woman's home. Appropriate written resources will be provided to participating pregnant women. Each participating pregnant woman will be given a written resource we have developed with pregnant women, 'Healthy food and lifestyle choices in pregnancy', which includes the Ministry of Primary Industries pullout guide to 'Food safety in pregnancy' and the Auckland District Health Board National Women's Health 'Being active during pregnancy' pamphlet.
Intervention code [1] 295087 0
Lifestyle
Intervention code [2] 295088 0
Prevention
Intervention code [3] 295089 0
Behaviour
Comparator / control treatment
This is a feasibility study to determine whether a proposed structured dietary intervention can be delivered in a 'real world' setting prior to underaking a randomised trial. There will be no control group in this feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298685 0
This is a feasibility study to determine the feasibility of delivering a structured dietary intervention delivery by Lead Maternity Carer midwives within routine antenatal care.
The length of time to deliver the intervention at each of the three dietary intervention visits. Median and range length of time for each of the three dietary intervention antenatal visits, as assessed by review of study attendance records.
Timepoint [1] 298685 0
End of pregnancy
Primary outcome [2] 299754 0
Number of additional separate antenatal visits for each participating woman to deliver the dietary intervention, as assessed by review of study attendance records.
Timepoint [2] 299754 0
End of pregnancy
Primary outcome [3] 299755 0
Attendance rate at additional antenatal visits, as assessed by review of study attendance records.
Timepoint [3] 299755 0
End of pregnancy
Secondary outcome [1] 324954 0
Maternal weight, as assessed by review of study attendance records and antenatal care notes.
Timepoint [1] 324954 0
End of pregnancy
Secondary outcome [2] 327772 0
Maternal body mass index (calculated from height and weight), as assessed by review of study attendance records and antenatal care notes. .
Timepoint [2] 327772 0
End of pregnancy
Secondary outcome [3] 327864 0
Mode of delivery, as assessed by review of antenatal care notes
Timepoint [3] 327864 0
At birth
Secondary outcome [4] 328034 0
Birth weight, as assessed by review of antenatal care notes
Timepoint [4] 328034 0
At birth

Eligibility
Key inclusion criteria
The inclusion criteria are:
- women with a singleton pregnancy
- antenatal booking at less than 15 weeks, ideally within the first trimester
- able to communicate in English
- planning to stay in the Southland (New Zealand) area for the duration of the pregnancy and birth at the local birthing unit
- aged 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are:
- any pre-existing health condition requiring antenatal obstetric specialist care at booking
- diabetes (any type)
- health condition requiring specialist dietic care eg coeliac disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
Simple descriptive analyses will be undertaken for both the primary and secondary outcome measures. Analysis of the primary outcomes will be undertaken to inform whether it is feasible to administer the intervention within current antenatal care systems. Analysis of secondary outcomes will be undertaken. for the purpose of informing the sample size calulations for the main intervention trial,

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2016
Actual
27/10/2016
Date of last participant enrolment
Anticipated
31/05/2017
Actual
7/04/2017
Date of last data collection
Anticipated
28/02/2018
Actual
31/10/2017
Sample size
Target
30
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 7975 0
New Zealand
State/province [1] 7975 0
Southland

Funding & Sponsors
Funding source category [1] 293870 0
University
Name [1] 293870 0
University of Otago
Country [1] 293870 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
362 Leith Street
North Dunedin
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 292697 0
Charities/Societies/Foundations
Name [1] 292697 0
Otago Southland Diabetes Trust
Address [1] 292697 0
c/- Perpetual Trust Ltd
83A Princes Street
Private Bag 1965.
Dunedin 9054.
Country [1] 292697 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295290 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 295290 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 295290 0
New Zealand
Date submitted for ethics approval [1] 295290 0
06/09/2016
Approval date [1] 295290 0
22/09/2016
Ethics approval number [1] 295290 0
16/NTA/151

Summary
Brief summary
Obesity in pregnancy is associated with adverse outcomes for both mother and baby. Obesity is common among New Zealand women of childbearing age (15-24 years: 17.9%, 25-34 years: 29.2%, 35-44 years: 33.1%). Preventing excess gestational weight gain (GWG) is an important component of antenatal care, but suitable interventions that can be readily provided as part of maternity care are lacking. Prior to a trial to evaluate the effect of a novel structured weight management intervention tool on GWG, a feasibility study will examine the practicalities of implementing the intervention tool as part of routine antenatal care and options for data collection.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1107 1107 0 0
/AnzctrAttachments/370931-Preg Weight Feasibility Study_Practice_Protocols_20160824.pdf (Protocol)

Contacts
Principal investigator
Name 66782 0
Dr Kirsten Coppell
Address 66782 0
Department of Medicine
University of Otago
PO BOX 56
Dunedin 9054
Country 66782 0
New Zealand
Phone 66782 0
+64 3 470 9074
Fax 66782 0
Email 66782 0
[email protected]
Contact person for public queries
Name 66783 0
Dr Kirsten Coppell
Address 66783 0
Department of Medicine
University of Otago
PO BOX 56
Dunedin 9054
Country 66783 0
New Zealand
Phone 66783 0
+64 3 470 9074
Fax 66783 0
Email 66783 0
[email protected]
Contact person for scientific queries
Name 66784 0
Dr Kirsten Coppell
Address 66784 0
Department of Medicine
University of Otago
PO BOX 56
Dunedin 9054
Country 66784 0
New Zealand
Phone 66784 0
+64 3 470 9074
Fax 66784 0
Email 66784 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
This was a feasibility study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo Coppell K, Paterson H, Norton J, Abel S, Drysdale ... [More Details]

Documents added automatically
No additional documents have been identified.