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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]

EU Horizon 2020 Grant Agreement Number 847984

Secondary ID [2]

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

Gestational diabetes

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Diet and Nutrition

Obesity

Metabolic and Endocrine

Diabetes

Reproductive Health and Childbirth

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]

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]

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]

Weight will be assessed at enrolment and 12 months postpartum (primary timepoint).

Secondary outcome [1]

Maternal Physical Activity as measured using the Pregnancy Physical Activity Questionnaire

Timepoint [1]

At enrolment, delivery and 12 months postpartum

Secondary outcome [2]

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]

Weight will be assessed at enrolment and delivery.

Secondary outcome [3]

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]

At delivery

Secondary outcome [4]

Diagnosis of gestational diabetes as measured using blood glucose (OGTT, FBG, HabA1c) and WHO diagnostic criteria

Timepoint [4]

During pregnancy, typically 24-28 weeks.

Secondary outcome [5]

Placental weight in grams as data linkage with medical records.

Timepoint [5]

At delivery

Secondary outcome [6]

Mode of delivery (instrumental, vaginal, caesarian section elective or emergency) from medical records

Timepoint [6]

At delivery

Secondary outcome [7]

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]

At delivery and at 12 months postpartum

Secondary outcome [8]

Breastfeeding duration as measured using an adapted version of the Infant Feeding Practices Study II questionnaire

Timepoint [8]

At 3, 6, 9, 12 months postpartum

Secondary outcome [9]

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]

At 12 months postpartum

Secondary outcome [10]

Infant diet will be assessed using the Complementary Food Frequency Questionnaire

Timepoint [10]

At 12 months postpartum

Secondary outcome [11]

Maternal diet assessed using the Food4Me Food Frequency questionnaire

Timepoint [11]