Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12624000926538
Ethics application status
Approved
Date submitted
9/07/2024
Date registered
31/07/2024
Date last updated
31/07/2024
Date data sharing statement initially provided
31/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Dietary Intake, Nutrition Beliefs and Attitudes of Pregnant Women with Inflammatory Bowel Disease
Query!
Scientific title
Dietary Intake, Nutrition Beliefs and Attitudes of Pregnant Women with Inflammatory Bowel Disease
Query!
Secondary ID [1]
312488
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease
334346
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
330993
330993
0
0
Query!
Inflammatory bowel disease
Query!
Reproductive Health and Childbirth
331101
331101
0
0
Query!
Normal pregnancy
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
This observational study will investigate the dietary intake, nutrition beliefs and attitudes of women in the second trimester of pregnancy attending a inflammatory bowel disease pregnancy clinic at a tertiary hospital. Participants will complete one 3-day electronic prospective food record (2 week days and 1 weekend day) and one electronic survey. Participants may be recruited in the first or second trimester, therefore timing of food record and survey completion relative to enrolment will vary. Participants recruited in the first trimester will be asked to complete the study requirements from 13 weeks gestation. Participants recruited in the second trimester are asked to complete the study requirements as soon as possible after enrolment, with the latest time to complete at 27 weeks gestation. The survey is estimated to take 10-12 minutes to complete. The food record is estimated to take 10 minutes per day to complete.
Query!
Intervention code [1]
329005
0
Not applicable
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
338761
0
Assessment of dietary intake relative to the Australian Dietary Guidelines.
Query!
Assessment method [1]
338761
0
Dietary intake data will be collected using a prospective 3-day food record. Core food group and discretionary servings will be calculated based on the serving sizes specified in the Australian Dietary Guidelines.
Query!
Timepoint [1]
338761
0
Collection of dietary intake data will occur over three days following enrolment.
Query!
Primary outcome [2]
338762
0
Attitudes and beliefs towards nutrition during pregnancy including how and why dietary intakes change, influence of IBD on dietary intake, and perceived importance of nutrition during pregnancy on maternal and foetal outcomes. All beliefs and attitudes will be assessed together as a composite outcome.
Query!
Assessment method [2]
338762
0
Qualitative analysis (thematic analysis) of survey answers. The survey was designed specifically for this study.
Query!
Timepoint [2]
338762
0
Participants will receive a link to complete the electronic survey immediately after the three day dietary data is collected.
Query!
Primary outcome [3]
338866
0
Assessment of dietary intake relative to the Nutrient Reference Values for Australia and New Zealand.
Query!
Assessment method [3]
338866
0
Dietary intake data will be collected using a prospective 3-day food record. Dietary intake data will be analysed using FoodWorks nutrition analysis software.
Query!
Timepoint [3]
338866
0
Collection of dietary intake data will occur over three days following enrolment.
Query!
Secondary outcome [1]
437360
0
Presence or absence of active inflammatory bowel disease.
Query!
Assessment method [1]
437360
0
Active inflammatory bowel disease is defined as an elevated faecal calprotectin >100ug/L and/or radiologic evidence of active inflammation on intestinal ultrasound (IUS) (bowel wall thickness >3mm). Participants are not required to undergo any tests such as blood tests, stool tests or scans for this study. Stool test and IUS results available from the medical records will be collected.
Query!
Timepoint [1]
437360
0
Single timepoint at recruitment.
Query!
Secondary outcome [2]
437361
0
Differences in dietary intake between participants with active and quiescent inflammatory bowel disease.
Query!
Assessment method [2]
437361
0
Dietary intake data will be collected using a prospective 3-day food record. Dietary intake data will be analysed using FoodWorks nutrition analysis software.
Query!
Timepoint [2]
437361
0
Collection of dietary intake data will occur over three days following enrolment.
Query!
Eligibility
Key inclusion criteria
• Adult females aged 18 years and older
• Confirmed diagnosis of IBD
• Presence of a singleton pregnancy between 13-27 weeks (second trimester)
• Receiving care in the hospital IBD Pregnancy Clinic
• Proficient at reading and writing in English
• Own a smartphone
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
• Presence of twin or higher order multiple pregnancy
• Patients receiving total parenteral nutrition
Query!
Study design
Purpose
Natural history
Query!
Duration
Cross-sectional
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/07/2024
Query!
Date of last participant enrolment
Anticipated
31/12/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
31/01/2025
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
1
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
26771
0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Query!
Recruitment postcode(s) [1]
42822
0
3065 - Fitzroy
Query!
Funding & Sponsors
Funding source category [1]
316908
0
University
Query!
Name [1]
316908
0
Australian Catholic University
Query!
Address [1]
316908
0
Query!
Country [1]
316908
0
Australia
Query!
Funding source category [2]
316999
0
Hospital
Query!
Name [2]
316999
0
St Vincent's Hospital Melbourne
Query!
Address [2]
316999
0
Query!
Country [2]
316999
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Emily Thompson, St Vincent's Hospital Melbourne
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
319157
0
None
Query!
Name [1]
319157
0
Query!
Address [1]
319157
0
Query!
Country [1]
319157
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315666
0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Query!
Ethics committee address [1]
315666
0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Query!
Ethics committee country [1]
315666
0
Australia
Query!
Date submitted for ethics approval [1]
315666
0
26/03/2024
Query!
Approval date [1]
315666
0
14/05/2024
Query!
Ethics approval number [1]
315666
0
Query!
Summary
Brief summary
This study aims to assess the dietary intake of pregnant women with inflammatory bowel disease (IBD), investigate the impact of IBD on dietary intake, and explore beliefs and attitudes towards nutrition during pregnancy. It is hypothesised that pregnant women with IBD, especially those with active IBD, are more likely to have dietary intakes that fall below the national dietary guideline targets compared to healthy pregnant cohorts. The findings could guide educational initiatives and interventions focused on improving the nutritional adequacy of dietary intakes and support provided to women with IBD during pregnancy. Enhancing maternal nutrition through tailored interventions could improve the health and well-being of both the mother and foetus, leading to better pregnancy outcomes.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
135434
0
Ms Emily Thompson
Query!
Address
135434
0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Query!
Country
135434
0
Australia
Query!
Phone
135434
0
+61 0392316950
Query!
Fax
135434
0
Query!
Email
135434
0
[email protected]
Query!
Contact person for public queries
Name
135435
0
Emily Thompson
Query!
Address
135435
0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Query!
Country
135435
0
Australia
Query!
Phone
135435
0
+61 0392312211
Query!
Fax
135435
0
Query!
Email
135435
0
[email protected]
Query!
Contact person for scientific queries
Name
135436
0
Emily Thompson
Query!
Address
135436
0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Query!
Country
135436
0
Australia
Query!
Phone
135436
0
+61 0392316950
Query!
Fax
135436
0
Query!
Email
135436
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF