None listed
Conditions
Brief summary
This randomised controlled trial of 120 pregnant people aims to evaluate the efficacy of a gut health-focused, smartphone-delivered, prenatal dietary program (Bugs & Bumps), compared to a smartphone-delivered program focused on the Australian Dietary Guidelines, for: (1) improving diet quality during pregnancy, (2) altering microbial or inflammatory biological pathways that may underpin neurodevelopment, and (3) influencing mental health-related outcomes in children.
Interventions
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 throu
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed