None listed
Conditions
Brief summary
Impact Diabetes Bump2Baby is a study to test whether women at high risk of developing diabetes can reduce that risk through a healthy eating and physical activity smartphone app and tele-health coaching. Women presenting to the maternity service for the first time will be assessed, using a validated set of questions, to determine the likelihood that they will develop gestational diabetes during their pregnancy. Women identified as at high risk will be invited to take part in a study study, to see if a personalised tele-health coaching service can help women with the self-management of modifiable lifestyle risk factors compared to women who will receive usual care. The tele-health coaching is provided through a smartphone application (app) called “Bump2Baby & Me”. This will guide a woman through the journey from pregnancy to birth and the end of the baby’s first year. Trained health coaches will optimise engagement with the app and help to personalise the behaviour change experience. The app is supported by a developed and tested commercial platform, that uses a health coach dashboard to coordinate and tailor engagement for each woman. The platform will integrate seamlessly with a woman’s smartphone and each site will have their own dedicated health coach. Our study will involve a woman during pregnancy and after birth will include her baby. During the first antenatal visit, all women will be screened for their risk of developing gestational diabetes using standard information collected at this visit such as age, body mass index, family history of diabetes. Women scoring 3 or higher will be eligible to take part. At the start, we will take blood samples, measure weight and height and ask the woman to fill out some questionnaires. Women in the intervention group will have access to the Bump2Baby & Me app and tele-health coach during pregnancy and for the first 12 months after their baby is born. At 12 months we will ask women to come in for a follow-up visit where we will repeat the blood samples, body measurements and questionnaires. We will ask a random sub-sample to take part in a short exit interview.
Interventions
The intervention consists of six related components:
i. Synchronous coaching sessions conducted on a 1:1 basis between the mHealth coach and
participants. There will be 2 synchronous sessions, the first at enrolment and the second between 4-8 weeks post-natal. These sessions typically last 45-50 minutes in length with a follow-up summary video message of the goals discussed and, at the beginning of the mother’s journey, the establishing of a change agreement. This is mediated through the live-vi
The intervention consists of six related components: i. Synchronous coaching sessions conducted on a 1:1 basis between the mHealth coach and participants. There will be 2 synchronous sessions, the first at enrolment and the second between 4-8 weeks post-natal. These sessions typically last 45-50 minutes in length with a follow-up summary video message of the goals discussed and, at the beginning of the mother’s journey, the establishing of a change agreement. This is mediated through the live-video feature in the Bump2Baby & Me mHealth coaching app. If the woman is diagnosed with GDM, there will be opportunity for a third 15-minute synchronous coaching session to review and adjust any lifestyle goals to align with the individual’s diabetes management plan ii. Asynchronous mHealth coaching that uses a combination of text and video messaging exchanges between the mHealth coach and participant. The pregnancy interactions will be once a week the first 4 weeks. The mHealth coaching then becomes bi-weekly for two months and then monthly until birth. The postpartum interactions will be after the synchronous coaching session. These will happen bi-weekly for one month, to support the woman to ease back into mHealth coaching contact after the birth. After that it will be weekly for a month, then biweekly for a month prior to monthly check-ins with the mHealth coach. However, this will be arranged with the woman during the postpartum synchronous coaching session and will be adapted accordingly. From 6-12 months postpartum, asynchronous coaching will happen monthly. iii. Automated push notifications are sent out to participants. These will include messages prompting the individual to follow through on the goals they have set for themselves, reminders to register goal achievements and motivational messages when they have accomplished their goals. Whilst these are standardized messages, they will be tailored to the individual’s goals, child feeding practice and preferences. iv. Participants will receive personalised educational content from their mHealth coach during the asynchronous coaching sessions. This content will cover topics within breastfeeding, healthy eating, physical activity, emotional wellbeing, and best practice formula feeding. The materials contained within the educational content is specifically designed for this intervention. Each mHealth coach will continuously assess what content is relevant before sending to the women. v. Participants will receive automated push notifications referring to additional content available in the Bump2Baby & Me app. The content push notifications will be active once a week during the weeks that no asynchronous mHealth coaching occurs. These push notifications will connect participants with specially designed online resources providing recipes, information, tips for food and activity choices, breastfeeding resources and links to relevant support agencies. vi. Participants will also have access to a virtual social network, through the mHealth coaching app, with other women participating in the study. This will enable social engagement and support, as well as the capacity to connect physically for shared activities, self-organised in each study site. Participants will be encouraged to engage with this network but engagement will be at the participant's discretion.
Sponsors
University College Dublin
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
> Women attending one of the four participating maternity services for their maternity care > Identified as at high risk of developing GDM, defined by the Monash Screening Questionnaire score of 3 or higher > Not currently in any other lifestyle-related clinical trial > Owner of a smartphone > Gestation <24 weeks
Exclusion criteria
> Established diabetes (T1DM or T2DM), previously known > Cancer (not in remission) > Severe mental illness in the last three months > Substance abuse in the last three months > Myocardial infarction in the last three months > Difficulty with using the English language for the Irish, English and Australian sites. Difficulty with using the Spanish language for the Spanish site. > Not owning a smartphone capable of hosting the intervention app > Greater than 24 weeks gestation > Current multiple pregnancy (e.g. twin, triplets)
Outcome results
None listed