Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000936426
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
14/07/2016
Date last updated
14/03/2019
Date data sharing statement initially provided
14/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting maternal diet for better child outcomes: The Healthy Parents, Healthy Kids Study
Scientific title
Targeting perinatal diet for better maternal and child outcomes: a randomised controlled trial
Secondary ID [1] 289510 0
None
Universal Trial Number (UTN)
U1111-1184-5171
Trial acronym
HPHK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut health in mothers and infants 299212 0
Immune system functioning in mothers and infants 299213 0
Dietary behaviours in women 299214 0
Condition category
Condition code
Oral and Gastrointestinal 299220 299220 0 0
Normal oral and gastrointestinal development and function
Inflammatory and Immune System 299331 299331 0 0
Normal development and function of the immune system
Diet and Nutrition 299332 299332 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to receiving treatment as usual, pregnant women allocated to the intervention group will attend a half-day educational dietary workshop at the beginning of their third trimester (3 months before birth). Recommendations and dietary advice delivered in the workshop is designed to promote a healthy gut microbiota. Participants will attend a small-group session delivered by a nutritionist (Master of Human Nutrition qualification) at the Royal Childrens Hospital campus in Parkville, Victoria, Australia. The same workshop presentation and script will be used for each workshop that is delivered. The Australian Dietary Guidelines provide the framework for the intervention, plus the inclusion of prebiotic and probiotic foods. Participants will be provided with NHMRC Healthy Eating During Pregnancy flyers, the ’My pregnancy plate’ guide (developed by dieticians at Oregon Health and Science University), along with a list of prebiotic and probiotic foods developed for this study. The workshop adopts behaviour change techniques for participants to set their own dietary goals within the context of the material presented, and to assist with adherence to their personal dietary goals. To support participants with their individual dietary goals, each participant will receive two 15-minute (max) follow-up support phone calls occurring 1 and 2 months prior to birth. These calls will follow a support phone call script that was written by the nutritionist, which is centred around goals, barriers and enablers for healthy eating. Members of our study team receive training to make these calls use the same script. Intervention adherence will be monitored through a register of attendance at the session, and via the support phone calls. Dietary adherence will be measured through dietary questionnaires that are collected at different time points; first one is collected before the intervention (3 months before birth), then followup data collection takes place after the workshop 1 and 2 months before birth and 1 month after birth (follow-up).
Intervention code [1] 295100 0
Behaviour
Intervention code [2] 295101 0
Lifestyle
Intervention code [3] 295243 0
Prevention
Comparator / control treatment
Participants allocated to the comparison group will continue receiving treatment as usual from their current healthcare provider (obstetrician, doctor, midwife). At the end of the study once recruitment has closed and the last participant has completed their final follow-up home visit, the control group participants will receive the same information that the intervention group received in written form. Depending on when participants were recruited over the 9 month recruitment period, there may be a wait time of between 0 and 9 months.
Control group
Active

Outcomes
Primary outcome [1] 298702 0
Markers of gut health measured using stool samples:
Fecal microbial diversity (Shannon index);
fecal microbiota organisational taxonomic units;
fecal short chain fatty acid concentrations (microbiota metabolites)
Timepoint [1] 298702 0
Baseline:
Women: beginning of third trimester (3 months before expected due date)
Follow-up:
Infants at 4-weeks of age
Mothers at 4-weeks post birth
Secondary outcome [1] 325008 0
Between group differences in biomarkers of inflammation:
Women;
- IL-6, IL1-beta, TNF-a, C-reactive protein (CRP) assessed by saliva assay
Infant:
- inflammatory panel assessed by a Proseek inflammatory panel using infant Guthrie spot (dry blood spot)
Timepoint [1] 325008 0
Baseline:
Women: beginning of third trimester (3 months before expected due date)
Follow-up:
Infants: 4-weeks of age
Mothers: 4-weeks post birth
Secondary outcome [2] 325009 0
Intervention efficacy in improving diet:
- Between group differences in dietary intake will be determined comparing longterm dietary intake at baseline and follow-up. This will be measured through validated food frequency questionnaire (cancer council dietary questionnaire for epidemiological studies)
Timepoint [2] 325009 0
Baseline measure:
Women: beginning of third trimester (3 months before expected due date)
Followup measure:
Women: 4-weeks after birth
Secondary outcome [3] 325010 0
Intervention efficacy and feasibility
- Trends in dietary intake over the 4 time points listed below using a separate simple dietary questionnaire (which has not been validated) representing dietary intake over the previous fortnight. This will also include analysis of the participant's level of participation (as measured by study records, attendance etc), and their motivation and readiness to improve their diet as measured by a questionnaire specifically designed for this study
Timepoint [3] 325010 0
Baseline measure:
Women: beginning of third trimester (3 months before expected due date)
Month 1 measure:
Women: 2-months before expected due date
Month 2 measure:
Women: 1-months before expected due date
Followup measure:
Women: 4-weeks after birth
Secondary outcome [4] 325644 0
Epigenetic markers will be assessed through buccal cell assays
Between group differences in:
- methylation of folate-sensitive gene ZFP57, (this is a protein coding gene, associated with diabetes mellitus);
- methylation of glucocorticoid receptor gene (NR3C1), (this is associated with stress-related disorders);
- methylation of acid receptor FFAR2/3, (this is a protein coding gene activated by short chain fatty acids, which are metabolites produced from fermentation of dietary fibre. FFAR2/3 is assocated with glucose metabolism and immunity);
- genome-wide methylation for differences in global methylation
Timepoint [4] 325644 0
Baseline:
Women: beginning of third trimester (3 months before expected due date)
Follow-up:
Infants: 4-weeks of age
Mothers: 4-weeks post birth

Eligibility
Key inclusion criteria
Participants will be included if they do not meet any of the exclusion criteria AND are:
1. Approaching week 26 of their pregnancy (third trimester) at the time of enrolment
2. Available to attend a Saturday morning workshop on offer as close to the beginning of week 26 of their pregnancy as possible

Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Under 18
2. No autonomy over own diet
3. Participant is uncomfortable communicating in English
4. Current diagnosis of a mental disorder (including: Major depression, Dysthymia, Anxiety disorder (generalised, social phobia, post traumatic stress disorder, Obsessive compulsive, Panic disorder), Eating disorder (Anorexia, Bulimia, Binge eating disorder), Psychotic disorder (Schizophrenia), Substance use disorder, Asperger’s, Autism disorder, ADHD, ADD)
5. Obesity, pre-pregnancy body mass index of 30 or above
6. Diabetes Mellitus (type 1, 2 or gestational diabetes)
7. Diagnosis of bowel disorder (inflammatory bowel disease (Crohn’s disease, ulcerative colitis) or irritable bowel syndrome)
8. Medically advised to follow on an exclusion/ restriction diet (e.g. low FODMAP)
9. Current antibiotic, prebiotic or probiotic supplement use (in the past month)
10. Regular illicit drug use

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is based upon differences between the treatment and control groups for faecal microbial composition of mothers and their babies. The primary outcome will be measured by the Shannon index, a measure of bacterial diversity which is based on the number of bacterial taxa with 97% similarity present, and their abundance. It is expected that maternal microbiota will readily respond to the diet given the evidence from recent dietary experiments, it is expected that it will be more difficult to detect differences in infant microbiota. Therefore, the sample size is geared to detect changes in infant microbiota. Recruitment of 90 mothers will allow for 80% power to detect of a one directional difference in Shannon index of at least 0.224 or a two-way difference of 0.254, which is comparable to differences in microbial diversity at 4-weeks of age reported in other studies. The sample size includes a tolerance of 10% lost to followup.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2016
Actual
24/07/2016
Date of last participant enrolment
Anticipated
18/04/2017
Actual
11/04/2017
Date of last data collection
Anticipated
Actual
27/09/2017
Sample size
Target
90
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6006 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 13428 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 293976 0
University
Name [1] 293976 0
Deakin University
Country [1] 293976 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University, School of Medicine, IMPACT SRC
PO Box 281
Geelong, VIC, 3220
Australia
Country
Australia
Secondary sponsor category [1] 292791 0
Other Collaborative groups
Name [1] 292791 0
Murdoch Children's Research Institute
Address [1] 292791 0
MCRI, Royal Childrens Hospital
50 Flemington Road,
Parkville, Vic, 3052
Australia
Country [1] 292791 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295375 0
Royal Childrens Hosptial HREC
Ethics committee address [1] 295375 0
Ethics committee country [1] 295375 0
Australia
Date submitted for ethics approval [1] 295375 0
07/09/2015
Approval date [1] 295375 0
16/06/2016
Ethics approval number [1] 295375 0
35200A
Ethics committee name [2] 295376 0
Deakin University HREC
Ethics committee address [2] 295376 0
Ethics committee country [2] 295376 0
Australia
Date submitted for ethics approval [2] 295376 0
01/02/2016
Approval date [2] 295376 0
28/06/2016
Ethics approval number [2] 295376 0
2016-036

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

Contacts
Principal investigator
Name 66814 0
A/Prof Felice Jacka
Address 66814 0
Deakin University, School of Medicine
IMPACT SRC, PO Box 281
Geelong, VIC, 3220
Country 66814 0
Australia
Phone 66814 0
+61 422194218
Fax 66814 0
Email 66814 0
[email protected]
Contact person for public queries
Name 66815 0
Samantha Dawson
Address 66815 0
Murdoch Childrens Research Institute
50 Flemington Road
Parkville VIC 3052
Australia
Country 66815 0
Australia
Phone 66815 0
+61 3 9936 6291
Fax 66815 0
Email 66815 0
[email protected]
Contact person for scientific queries
Name 66816 0
Felice N Jacka
Address 66816 0
Deakin University, School of Medicine
IMPACT SRC, PO Box 281
Geelong, VIC, 3220
Australia
Country 66816 0
Australia
Phone 66816 0
+61422194218
Fax 66816 0
Email 66816 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
Public data sharing was not included in the Participant Information and Consent Form, nor was it included in the Ethics application.


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.