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Trial registered on ANZCTR


Registration number
ACTRN12620001240932
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
19/11/2020
Date last updated
16/07/2021
Date data sharing statement initially provided
19/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Bump 2 Baby and Me: A study to test health coaching for healthy eating and activity during pregnancy and the first year after a baby is born
Scientific title
Implementation Action to prevent Diabetes from
Bump 2 Baby (IMPACT DIABETES B2B): Investigating the impact of a low-resource system of care intervention on maternal weight gain at 12 month postpartum
Secondary ID [1] 301541 0
EU Horizon 2020 Grant Agreement Number 847984
Secondary ID [2] 301543 0
NHMRC APP1194234
Universal Trial Number (UTN)
U1111-1253-3791
Trial acronym
IDB2B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight management 317902 0
Gestational diabetes 319433 0
Condition category
Condition code
Reproductive Health and Childbirth 315938 315938 0 0
Normal pregnancy
Diet and Nutrition 315939 315939 0 0
Obesity
Metabolic and Endocrine 315940 315940 0 0
Diabetes
Reproductive Health and Childbirth 315941 315941 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317842 0
Lifestyle
Comparator / control treatment
Usual care for pregnancy involves routine visits to the hospital for antenatal appointments with a specified care team (midwifery or medical doctor led). Postpartum usual care involves woman and infant scheduled check-ups provided by community midwifes and public health nurses.
Control group
Active

Outcomes
Primary outcome [1] 325190 0
Change in maternal body mass index (BMI) measured using weight and height. Weight will be determined using a digital scales and height will be determined using a stadiometer.
Timepoint [1] 325190 0
Weight will be assessed at enrolment and 12 months postpartum (primary timepoint).
Secondary outcome [1] 387128 0
Maternal Physical Activity as measured using the Pregnancy Physical Activity Questionnaire
Timepoint [1] 387128 0
At enrolment, delivery and 12 months postpartum
Secondary outcome [2] 387129 0
Change in maternal BMI measured using weight and height. Weight will be determined using a digital scales and height will be determined using a stadiometer.
Timepoint [2] 387129 0
Weight will be assessed at enrolment and delivery.
Secondary outcome [3] 387130 0
Birth complications as any recorded medical chart entries of known birth complications including admission to the special care nursery and/or neonatal hypoglycaemia.
Timepoint [3] 387130 0
At delivery
Secondary outcome [4] 387131 0
Diagnosis of gestational diabetes as measured using blood glucose (OGTT, FBG, HabA1c) and WHO diagnostic criteria
Timepoint [4] 387131 0
During pregnancy, typically 24-28 weeks.
Secondary outcome [5] 387132 0
Placental weight in grams as data linkage with medical records.
Timepoint [5] 387132 0
At delivery
Secondary outcome [6] 387133 0
Mode of delivery (instrumental, vaginal, caesarian section elective or emergency) from medical records
Timepoint [6] 387133 0
At delivery
Secondary outcome [7] 387134 0
Infant weight (kg), height (cm) and head circumference (cm) as data linkage with medical records and actual measured using digital infant scales, flexible measuring tape and length measurement board..
Timepoint [7] 387134 0
At delivery and at 12 months postpartum
Secondary outcome [8] 387135 0
Breastfeeding duration as measured using an adapted version of the Infant Feeding Practices Study II questionnaire
Timepoint [8] 387135 0
At 3, 6, 9, 12 months postpartum
Secondary outcome [9] 387141 0
Infant physical activity measured using parent/caregiver self-reported survey questions.

The questions will be taken from those developed for Lioret S, Campbell KJ, McNaughton SA, Cameron AJ, Salmon J, Abbott G, Hesketh KD: Lifestyle patterns begin in early childhood, persist and are socioeconomically patterned, confirming the importance of early life interventions. Nutrients 2020, 12(3).
Timepoint [9] 387141 0
At 12 months postpartum
Secondary outcome [10] 387143 0
Infant diet will be assessed using the Complementary Food Frequency Questionnaire
Timepoint [10] 387143 0
At 12 months postpartum
Secondary outcome [11] 387145 0
Maternal diet assessed using the Food4Me Food Frequency questionnaire
Timepoint [11] 387145 0
At enrolment and 12 months postpartum
Secondary outcome [12] 387150 0
Maternal blood glucose as measured within non-fasting blood sample and automated analyzer after calibration with the appropriate standards.
Timepoint [12] 387150 0
At enrolment and 12 months postpartum
Secondary outcome [13] 387151 0
Maternal blood lipids (total cholesterol, high density and low density lipoproteins, triglycerides) from plasma measured on an automated analyzer after calibration with the appropriate standards.
Timepoint [13] 387151 0
At enrolment and 12 months postpartum
Secondary outcome [14] 387152 0
Maternal glycated haemoglobin A1c as measured using standard auto analyser methods on plasma sample
Timepoint [14] 387152 0
At enrolment and 12 months postpartum
Secondary outcome [15] 387153 0
Maternal blood pressure as measured using sphygmomanometer and a standard protocol
Timepoint [15] 387153 0
At enrolment and 12 months postpartum
Secondary outcome [16] 387958 0
Breastfeeding exclusivity as measured using an adapted version of the Infant Feeding Practices Study II questionnaire
Timepoint [16] 387958 0
At 3 months and 6 months
Secondary outcome [17] 387959 0
Infant sedentary time measured using parent/caregiver self-reported survey questions.

The questions will be taken from those developed for Lioret S, Campbell KJ, McNaughton SA, Cameron AJ, Salmon J, Abbott G, Hesketh KD: Lifestyle patterns begin in early childhood, persist and are socioeconomically patterned, confirming the importance of early life interventions. Nutrients 2020, 12(3).
Timepoint [17] 387959 0
At 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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)

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)
Allocation will be recorded in sequentially numbered and sealed, opaque envelopes, which will be distributed to the four study sites by the trial Biostatistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be generated centrally by the trial biostatistician using a computer-generated random sequence. For each participant, the researcher at each site will select the next sequential envelope and open it in front of an independent witness.
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
The intervention arm will be tested against usual care. Intention to treat (ITT) and per protocol (PP) analyses will be planned for both primary and secondary outcomes. The statistical analysis will consist of a between-group repeated measures analysis, using a marginal model to allow for a given correlation structure of BMI across measurement time-points. An unstructured variance-covariance matrix, over time, will be estimated, in the absence of strong a priori knowledge of the correlations from time-point to time-point. The loss of degrees of freedom in the estimation of each variance and covariance parameter separately is preferable to a misspecification of the structure. The trial result will be decided by a contrast of the change over time, between arms. Covariates included in this model will be kept to a minimum – site is the only covariate expected. The baseline BMI measurement will be included in the dependent variable as the first time-point and thus inherently controlled for. The impact of loss to follow-up will be minimised by using a marginal model, which is not subject to list-wise deletion: each participant will contribute all time-specific measurements made to the model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/01/2021
Actual
9/02/2021
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
800
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17592 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 17594 0
Casey Hospital - Berwick
Recruitment hospital [3] 17595 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 31336 0
3168 - Clayton
Recruitment postcode(s) [2] 31338 0
3806 - Berwick
Recruitment postcode(s) [3] 31339 0
3175 - Dandenong
Recruitment outside Australia
Country [1] 23002 0
Ireland
State/province [1] 23002 0
Dublin
Country [2] 23003 0
United Kingdom
State/province [2] 23003 0
Bristol
Country [3] 23006 0
Spain
State/province [3] 23006 0
Granada

Funding & Sponsors
Funding source category [1] 305978 0
Government body
Name [1] 305978 0
National Health and Medical Research Council (NHMRC)
Country [1] 305978 0
Australia
Funding source category [2] 306792 0
Government body
Name [2] 306792 0
Horizon 2020; EU Research and Innovation programme
Country [2] 306792 0
Belgium
Primary sponsor type
University
Name
University College Dublin
Address
Research Office, University College Dublin, Belfield, Dublin 4, Ireland
Country
Ireland
Secondary sponsor category [1] 307347 0
University
Name [1] 307347 0
Monash University
Address [1] 307347 0
Monash Centre for Health Research and Implementation, Monash University
Locked Bag 29
Clayton VIC 3168
Country [1] 307347 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306218 0
Research Ethics Committee, The National Maternity Hospital
Ethics committee address [1] 306218 0
Holles street, Dublin 2
Ethics committee country [1] 306218 0
Ireland
Date submitted for ethics approval [1] 306218 0
01/06/2020
Approval date [1] 306218 0
23/06/2020
Ethics approval number [1] 306218 0
EC 18.2020

Summary
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.
Trial website
https://bump2babyandme.org/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103138 0
Dr Sharleen O'Reilly
Address 103138 0
School of Agriculture and Food Science,
Room 2.16 Science South,
University College Dublin,
Belfield, Dublin 4,Ireland.
Country 103138 0
Ireland
Phone 103138 0
+353871716440
Fax 103138 0
Email 103138 0
[email protected]
Contact person for public queries
Name 103139 0
Faisal Zahoor
Address 103139 0
School of Agriculture and Food Science,
Room 2.58 Science South,
University College Dublin,
Belfield, Dublin 4,Ireland.
Country 103139 0
Ireland
Phone 103139 0
+353894677598
Fax 103139 0
Email 103139 0
[email protected]
Contact person for scientific queries
Name 103140 0
Sharleen O'Reilly
Address 103140 0
School of Agriculture and Food Science,
Room 2.16 Science South,
University College Dublin,
Belfield, Dublin 4,Ireland.
Country 103140 0
Ireland
Phone 103140 0
+353871716440
Fax 103140 0
Email 103140 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?
De-identified outcome data will be made available using the FAIR principles.
When will data be available (start and end dates)?
The data will be available after Dec 2024. No end date specified.
Available to whom?
Data may be made available upon request with a methodologically sound proposal and with ethics approval.
Available for what types of analyses?
Meta-analyses.
How or where can data be obtained?
A metadata fiche, for each IDB2B data collection, will be made publicly accessible through Zenodo (https://zenodo.org/). Zenodo is an open access, open source, open data platform. IPD will be made available by emailing the Principal Investigator - Dr Sharleen O'Reilly, University College Dublin, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9241Study protocol https://bump2babyandme.org/publications/  The study protocol will be peer reviewed and publi... [More Details]
9242Informed consent form  [email protected]
9243Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children.2021https://dx.doi.org/10.1186/s13063-021-05892-4
N.B. These documents automatically identified may not have been verified by the study sponsor.