Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001343695
Ethics application status
Approved
Date submitted
15/09/2023
Date registered
20/12/2023
Date last updated
31/05/2024
Date data sharing statement initially provided
20/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Bugs & Bumps study: the effect of a smartphone app on diet quality in pregnancy to support maternal and child mental health-related outcomes
Scientific title
The Bugs & Bumps RCT Study: Investigating the effect of gut-focused prenatal dietary advice on maternal diet quality, early life microbiome, inflammation, and child socio-emotional and neurocognitive outcomes
Secondary ID [1] 310592 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor prenatal diet quality 331453 0
Poorer prenatal mental wellbeing 331454 0
Disturbances in the prenatal vaginal microbiome 331459 0
Disturbances in the maternal gut microbiome 331462 0
Elevated inflammatory markers in pregnancy 331464 0
Elevated child emotional behaviour problems 331468 0
Developmental trajectory of the infant gut microbiome 331573 0
Elevated inflammatory markers in infancy 331575 0
Poorer child neurocognition 331577 0
Poorer child temperament 331578 0
Elevated respiratory health problems 331716 0
Elevated allergies 331717 0
Poorer pregnancy outcomes 332046 0
Poorer infant diet quality 332047 0
Condition category
Condition code
Diet and Nutrition 328194 328194 0 0
Other diet and nutrition disorders
Mental Health 328195 328195 0 0
Depression
Mental Health 328196 328196 0 0
Anxiety
Mental Health 328197 328197 0 0
Studies of normal psychology, cognitive function and behaviour
Inflammatory and Immune System 328209 328209 0 0
Normal development and function of the immune system
Oral and Gastrointestinal 328210 328210 0 0
Normal oral and gastrointestinal development and function
Reproductive Health and Childbirth 328211 328211 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Starting from week 26 of pregnancy until birth, women in the intervention group will receive a 10-week gut health-focused, smartphone-delivered, prenatal dietary program (Bugs & Bumps).

The Bugs & Bumps dietary intervention app delivers eight simple dietary education topics, encompassing 120 short Instagram-style videos, over a total of 57:53 minutes. Each video is very brief (< 1 minute) and can be stopped and started at any time. Women are asked to use the app from week 26 of pregnancy through to when their babies are born. Participants will watch the videos at their own pace, and set their first goal within the first week of the program.

The eight topics are: 1. Introduction to the app, 2. Food Safety, 3. What you eat (what your diet is made up of), 4. Education about eating for health and wellbeing, 5. Education about what your gut bugs do, 6. Eating for your gut bugs - dietary advice based on the Australian Dietary Guidelines (ADG), 7. Activities for how to plate up meals and supercharge them with specific ingredients, and 8. Goal setting. The dietary advice in topic 6 is focused on ‘eating for their gut bugs’, which involves adhering to the ADG and increasing intakes of prebiotic foods and common fermented foods.

The program capitalises on app-based features that deliver with behaviour setting techniques such as:
- Goal setting and monitoring;
- Links to question / answer style content to address barriers and enablers to change;
- Automated dietary monitoring (i.e., completing the Short Diet Questionnaire tool) and feedback. Feedback is based on the scores from the dietary questionnaire. to help improve their diet qualty, This feedback was designed by two Accredited Practicing Dietitians and the study investigator.
- Demonstration using a plate-based guide based on the ADG food proportions; Prompts and printable resources - all of the printable resources were designed especially for this study, except for the "Nutrition advice during pregnancy" information sheet (https://www.health.gov.au/resources/publications/nutrition-advice-during-pregnancy).
-App-based reminders are used to reinforce behaviour change and retain engagement, including prompts to use the dietary monitoring feedback tool and set and review their goals.
Intervention code [1] 326999 0
Behaviour
Intervention code [2] 327000 0
Lifestyle
Intervention code [3] 327001 0
Prevention
Comparator / control treatment
Starting from week 26 of pregnancy until birth, women in the control group will receive a 10-week smartphone-delivered, prenatal dietary program that delivers a subset of the Bugs & Bumps program.

The control condition will receive a cut-down version of the Bugs & Bumps program which aims to improve prenatal diet quality, aligned with the Australian Dietary Guidelines. The comparison program delivers seven simple dietary education topics, encompassing 54 short Instagram-style videos, over a total of 22:22 minutes. Each video is very brief (< 1 minute) and can be stopped and started at any time. Women are asked to use the app from week 26 of pregnancy through to when their babies are born. Participants will watch the videos at their own pace, and set their first goal within the first week of the program. The seven topics are: 1. Introduction; 2. Food safety; 3. What you eat; 4. Eating a rainbow of fresh foods with the Australian dietary guidelines; 5. Limiting processed snack foods and drinks; 6. Using the bugs & bumps plate; 7. Goal setting. The dietary advice in 5 and 6 deliver the same Australian Dietary Guideline content as the intervention. Behaviour change techniques that are used in the full program are also implemented; the control group will be able to set their own dietary goals and monitor their intakes and receive automated feedback for foods relating to dietary messages 5 and 6 above.
Control group
Active

Outcomes
Primary outcome [1] 336072 0
Between-group change from baseline over time in maternal diet quality as measured by the Simple Dietary Questionnaire - Gut (SDQ-gut) dietary questionnaire
Timepoint [1] 336072 0
10-weeks post-intervention start (36-weeks gestation - primary timepoint)
Secondary outcome [1] 426747 0
Between-group change from baseline in the alpha diversity of maternal stool samples measured using metagenomic sequencing.
Timepoint [1] 426747 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [2] 426748 0
Between-group change from baseline in the beta diversity of maternal stool samples measured in stool using metagenomic sequencing.
Timepoint [2] 426748 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [3] 426751 0
Between-group change from baseline over time in maternal depression symptoms using scores on the Edinburgh Postnatal Depression Scale
Timepoint [3] 426751 0
5 weeks post-intervention (31 weeks gestation)
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [4] 426753 0
Between-group change from baseline over time in maternal dietary variety as measured using the SDQ-gut dietary questionnaire
Timepoint [4] 426753 0
5 weeks post-intervention (31 weeks gestation)
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [5] 426754 0
Between-group difference over time in the alpha diversity of infant stool samples measured using metagenomic sequencing.
Timepoint [5] 426754 0
1-week of age
4 weeks of age,
12 months of age
Secondary outcome [6] 426755 0
Between-group differences in infant temperament scores as measured using the Revised Infant Temperament Questionnaire
Timepoint [6] 426755 0
9 months of age
Secondary outcome [7] 426788 0
Between-group differences in maternal urinary metabolites measured by Nuclear Magnetic Resonance spectroscopy
Timepoint [7] 426788 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [8] 426790 0
Between-group changes in maternal GlycA in measured in blood serum
Timepoint [8] 426790 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [9] 427731 0
Between-group change from baseline over time in maternal dietary intake of discretionary foods as measured using the SDQ-gut dietary questionnaire
Timepoint [9] 427731 0
5 weeks post-intervention (31 weeks gestation)
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [10] 427732 0
Between-group change from baseline over time in maternal dietary intake of prebiotic-containing food intakes as measured using the SDQ-gut dietary questionnaire
Timepoint [10] 427732 0
5 weeks post-intervention (31 weeks gestation)
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [11] 427733 0
Between-group change from baseline over time in maternal dietary intake of fermented food intakes as measured using the SDQ-gut dietary questionnaire
Timepoint [11] 427733 0
5 weeks post-intervention (31 weeks gestation)
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [12] 427734 0
Between-group change from baseline over time in maternal anxiety symptoms using scores on the Edinburgh Postnatal Depression Scale
Timepoint [12] 427734 0
5 weeks post-intervention (31 weeks gestation)
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [13] 427736 0
Between-group change from baseline in the differentially abundant taxa of maternal stool samples measured using metagenomic sequencing.
Timepoint [13] 427736 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [14] 427739 0
Between-group change from baseline in P. copri in maternal stool samples measured using metagenomic sequencing.
Timepoint [14] 427739 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [15] 427740 0
Between-group change from baseline in Lachnospiraceae in maternal stool samples measured using metagenomic sequencing.
Timepoint [15] 427740 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [16] 427741 0
Between-group change from baseline in Ruminococcaceae in maternal stool samples measured using metagenomic sequencing.
Timepoint [16] 427741 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [17] 427750 0
Between-group change from baseline in butyrate producing capacity of maternal stool samples measured using metagenomic sequencing.
Timepoint [17] 427750 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [18] 427751 0
Between-group differences in maternal urinary Hippurate measured by Nuclear Magnetic Resonance spectroscopy
Timepoint [18] 427751 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [19] 427752 0
Between-group differences in maternal differential abundance in vaginal microbiome composition measured by metagenomic sequencing.
Timepoint [19] 427752 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [20] 427755 0
Between-group differences in infant socio-emotional behaviour scores as measured using the Brief Infant and Toddler Social Emotional Assessment at 12-months
Timepoint [20] 427755 0
12 months of age
Secondary outcome [21] 427758 0
Between-group difference over time in the beta diversity of infant stool samples measured using metagenomic sequencing.
Timepoint [21] 427758 0
1-week of age
Secondary outcome [22] 427759 0
Between-group difference over time in the differentially abundant taxa of infant stool samples measured using metagenomic sequencing.
Timepoint [22] 427759 0
1-week of age
Secondary outcome [23] 427760 0
Between-group difference over time in the microbiome maturation trajectory of infant stool samples measured using metagenomic sequencing.
Timepoint [23] 427760 0
1-week of age
Secondary outcome [24] 427761 0
Between-group differences of infant systemic inflammation measured as GlycA in Guthrie blood spots
Timepoint [24] 427761 0
Birth
Secondary outcome [25] 427762 0
Between-group difference over time in infant allergies as measured by the International Study of Asthma and Allergies in Childhood scale
Timepoint [25] 427762 0
18-months of age
Secondary outcome [26] 427763 0
Between-group difference over time in infant respiratory health as measured by the International Study of Asthma and Allergies in Childhood scale
Timepoint [26] 427763 0
18-months of age
Secondary outcome [27] 427777 0
Between-group change sustained throughout the postnatal period in maternal depression symptoms using scores on the Edinburgh Depression Scale
Timepoint [27] 427777 0
1-month post-birth
9-months post-birth
12-months post-birth
18-months post-birth
Secondary outcome [28] 427778 0
Between-group change sustained throughout the postnatal period in maternal anxiety symptoms using scores on the Edinburgh Depression Scale
Timepoint [28] 427778 0
1-month post-birth
9-months post-birth
12-months post-birth
18-months post-birth
Secondary outcome [29] 427779 0
Between-group differences in maternal differential abundance in vaginal microbiome function measured by metagenomic sequencing.
Timepoint [29] 427779 0
10-weeks post-intervention (36-weeks gestation)
Secondary outcome [30] 427780 0
Between-group difference over time in the functional pathways of infant stool samples measured using metagenomic sequencing.
Timepoint [30] 427780 0
1-week of age
Secondary outcome [31] 427785 0
Between-group differences in infant adaptive skills scores using the clinician assessed Bayley Scales of Infant and Toddler Development
Timepoint [31] 427785 0
18 months of age
Secondary outcome [32] 427786 0
Between-group differences in infant cognitive scores using the clinician assessed Bayley Scales of Infant and Toddler Development
Timepoint [32] 427786 0
18 months of age
Secondary outcome [33] 427787 0
Between-group differences in infant language scores using the clinician assessed Bayley Scales of Infant and Toddler Development
Timepoint [33] 427787 0
18 months of age
Secondary outcome [34] 427788 0
Between-group differences in infant motor scores using the clinician assessed Bayley Scales of Infant and Toddler Development
Timepoint [34] 427788 0
18 months of age
Secondary outcome [35] 427789 0
Between-group differences in infant social-emotional scores using the clinician assessed Bayley Scales of Infant and Toddler Development
Timepoint [35] 427789 0
18 months of age
Secondary outcome [36] 427790 0
Between-group differences in infant internalising and externalising behaviour problem scores as measured using the Child Behaviour Checklist
Timepoint [36] 427790 0
18 months of age
Secondary outcome [37] 428851 0
Gestational diabetes measured by self-report during eliciting of adverse events.
Timepoint [37] 428851 0
Birth
Secondary outcome [38] 428852 0
Pre-eclampsia measured by self-report during eliciting of adverse events.
Timepoint [38] 428852 0
Birth
Secondary outcome [39] 428853 0
Preterm birth measured by self-report during Birth and Infant Health questionnaire.
Timepoint [39] 428853 0
Birth
Secondary outcome [40] 428854 0
Caesarean section rates measured by self-report during Birth and Infant Health questionnaire..
Timepoint [40] 428854 0
Birth

Eligibility
Key inclusion criteria
• Are able to participate and attend the study visits on Ryrie St, Geelong
• Are adults aged 18 years or older
• Are currently pregnant and less than 26-weeks’ gestation
• Will be 26 weeks gestation by the 21st week of recruitment
• Use a smartphone with internet access
• Have capacity to provide informed consent and understand written and spoken English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Are under 18 years of age
• Antibiotic use in the last 30 days
• Are following a medically-indicated diet, for example, currently seeing a dietitian for a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) trial, or managing intensive food intolerances
• Have current, or history of, a formal diagnosis and/or treatment for diabetes (Type 1, Type 2 and/or gestational diabetes) as the participant may already be receiving specific dietary management.
• Are following a dietary pattern where carbohydrates are restricted, for example, a ‘Paleo’ or ‘Keto’ diet, as the participant would not be able to adhere to the program and increase their grain intakes
• Have severe food allergies, intolerances, aversions, or malabsorption issues
• Have a diagnosed major bowel condition (e.g., Coeliac’s disease, inflammatory bowel diseases including Crohn’s disease and ulcerative colitis, bowel cancer) or have recently undergone major gastrointestinal surgery, as the intervention may not be appropriate
• Are participating in another study that involves an intervention as this would introduce heterogeneity and bias
• Have a current, or history of, a formal diagnosis and/or treatment for an eating disorder as the programs were not designed for this population
• Have a current, or history of, a formal diagnosis and/or treatment for substance use disorder
• Lack of dietary autonomy, for example has no control over what groceries are bought as this could limit on adherence to the program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed as a statistician not directly involved with participants or the analysis will prepare the randomisation schedule using block randomisation to maintain balance between treatment arms. Allocation is concealed as the research nurse confirming eligibility of participants will not know the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be used with a 1:1 group allocation ratio with randomly permuted block sizes to ensure allocation to treatment concealment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalised estimating equations will be used for the primary outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25522 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 41343 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 314807 0
University
Name [1] 314807 0
Deakin University
Country [1] 314807 0
Australia
Funding source category [2] 314808 0
Charities/Societies/Foundations
Name [2] 314808 0
Waterloo Foundation
Country [2] 314808 0
United Kingdom
Funding source category [3] 314819 0
Government body
Name [3] 314819 0
NHMRC
Country [3] 314819 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Rd Waurn Ponds VIC 3216
Country
Australia
Secondary sponsor category [1] 316793 0
None
Name [1] 316793 0
Address [1] 316793 0
Country [1] 316793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313812 0
Barwon Health Human Ethics Committee
Ethics committee address [1] 313812 0
Ethics committee country [1] 313812 0
Australia
Date submitted for ethics approval [1] 313812 0
28/09/2023
Approval date [1] 313812 0
25/01/2024
Ethics approval number [1] 313812 0
Ethics committee name [2] 315434 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 315434 0
Ethics committee country [2] 315434 0
Australia
Date submitted for ethics approval [2] 315434 0
01/02/2024
Approval date [2] 315434 0
23/02/2024
Ethics approval number [2] 315434 0
2024-030

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

Contacts
Principal investigator
Name 129422 0
Dr Samantha Dawson
Address 129422 0
Health Education & Research Building, Barwon Health, 285 Ryrie St, Geelong VIC 3220
Country 129422 0
Australia
Phone 129422 0
+61 3 522 73875
Fax 129422 0
Email 129422 0
[email protected]
Contact person for public queries
Name 129423 0
Samantha Dawson
Address 129423 0
Health Education & Research Building, Barwon Health, 285 Ryrie St, Geelong VIC 3220
Country 129423 0
Australia
Phone 129423 0
+61 3 522 73875
Fax 129423 0
Email 129423 0
[email protected]
Contact person for scientific queries
Name 129424 0
Samantha Dawson
Address 129424 0
Health Education & Research Building, Barwon Health, 285 Ryrie St, Geelong VIC 3220
Country 129424 0
Australia
Phone 129424 0
+61 3 522 73875
Fax 129424 0
Email 129424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Microbiome sequence data only, deidentified with the only meta-data as: group (program 1 or program 2), donor type (maternal or infant) and collection timepoint.
When will data be available (start and end dates)?
This needs to be uploaded to a repository when the results are published in a journal article and avialible ongoing. Estimated start 1/11/2026 and no end date.
Available to whom?
Public
Available for what types of analyses?
Microbiome analyses
How or where can data be obtained?
From the online microbiome repository which is to be confirmed. The interim contact person is Dr Samantha Dawson ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20353Statistical analysis plan    The statistical analysis plan for each publication... [More Details]



Results publications and other study-related documents

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

Documents added automatically
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