None listed
Conditions
Brief summary
There’s still so much we don’t know about how diet might affect the health of pregnant women and their babies. A healthy diet during pregnancy is recommended for good health, but many women find it difficult to eat healthily during pregnancy. We’ve developed an educational dietary program and would like to see how it compares to the support and dietary advice that women receive from their healthcare providers during pregnancy in influencing various health endpoints. This study is recruiting women in their second trimester (14 - 25 weeks) of pregnancy, so that they can participate in the study from the beginning of their third trimester (week 26), through to 4 weeks after their babies are born. What will the research achieve? The study will evaluate whether the program is helpful in supporting pregnant women to eat healthily during their pregnancy, and whether the procedures are practical and feasible. It also assesses the possible effect of the dietary program on certain biological aspects of health in pregnant women and their babies.
Interventions
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, Victo
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).
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed