Trial Review

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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
Scientific title
Dietary Intake, Nutrition Beliefs and Attitudes of Pregnant Women with Inflammatory Bowel Disease
Secondary ID [1] 312488 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 334346 0
Condition category
Condition code
Oral and Gastrointestinal 330993 330993 0 0
Inflammatory bowel disease
Reproductive Health and Childbirth 331101 331101 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 329005 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338761 0
Assessment of dietary intake relative to the Australian Dietary Guidelines.
Timepoint [1] 338761 0
Collection of dietary intake data will occur over three days following enrolment.
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.
Timepoint [2] 338762 0
Participants will receive a link to complete the electronic survey immediately after the three day dietary data is collected.
Primary outcome [3] 338866 0
Assessment of dietary intake relative to the Nutrient Reference Values for Australia and New Zealand.
Timepoint [3] 338866 0
Collection of dietary intake data will occur over three days following enrolment.
Secondary outcome [1] 437360 0
Presence or absence of active inflammatory bowel disease.
Timepoint [1] 437360 0
Single timepoint at recruitment.
Secondary outcome [2] 437361 0
Differences in dietary intake between participants with active and quiescent inflammatory bowel disease.
Timepoint [2] 437361 0
Collection of dietary intake data will occur over three days following enrolment.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Presence of twin or higher order multiple pregnancy
• Patients receiving total parenteral nutrition

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/07/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26771 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 42822 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 316908 0
University
Name [1] 316908 0
Australian Catholic University
Country [1] 316908 0
Australia
Funding source category [2] 316999 0
Hospital
Name [2] 316999 0
St Vincent's Hospital Melbourne
Country [2] 316999 0
Australia
Primary sponsor type
Individual
Name
Emily Thompson, St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319157 0
None
Name [1] 319157 0
Address [1] 319157 0
Country [1] 319157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315666 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 315666 0
Ethics committee country [1] 315666 0
Australia
Date submitted for ethics approval [1] 315666 0
26/03/2024
Approval date [1] 315666 0
14/05/2024
Ethics approval number [1] 315666 0

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

Contacts
Principal investigator
Name 135434 0
Ms Emily Thompson
Address 135434 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Country 135434 0
Australia
Phone 135434 0
+61 0392316950
Fax 135434 0
Email 135434 0
Emily.Thompson@svha.org.au
Contact person for public queries
Name 135435 0
Emily Thompson
Address 135435 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Country 135435 0
Australia
Phone 135435 0
+61 0392312211
Fax 135435 0
Email 135435 0
Emily.Thompson@svha.org.au
Contact person for scientific queries
Name 135436 0
Emily Thompson
Address 135436 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Country 135436 0
Australia
Phone 135436 0
+61 0392316950
Fax 135436 0
Email 135436 0
Emily.Thompson@svha.org.au

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.