Bonding Before Birth: An mHealth Intervention for first-time expectant couples
| ISRCTN | ISRCTN15166640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15166640 |
| Secondary identifying numbers | 2023-068 |
- Submission date
- 24/10/2025
- Registration date
- 29/10/2025
- Last edited
- 29/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study is looking at whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.
Who can participate?
Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English.
What does the study involve?
Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.
What are the possible benefits and risks of participating?
Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health during pregnancy. There are no known major risks, but some people might find the surveys or tasks time-consuming or emotionally difficult.
Where is the study run from?
Institute for Human Development and Potential, A*STAR (Singapore)
When is the study starting and how long is it expected to run for?
March 2022 to December 2028
Who is funding the study?
Institute for Human Development and Potential, A*STAR (Singapore)
Who is the main contact?
b3_study@a-star.edu.sg
Contact information
Scientific, Principal investigator
30 Medical Drive
Singapore
117609
Singapore
 ORCID ID |
0000-0002-4426-4521 |
|---|---|
| Phone | +65-64070100 |
| michelle_kee@a-star.edu.sg |
Public
30 Medical Drive
Singapore
117609
Singapore
| Phone | +65-64070100 |
|---|---|
| b3_study@a-star.edu.sg |
Study information
| Study design | Single-center interventional two-arm cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Internet/virtual, Laboratory |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Bonding Before Birth: a cluster-randomized, controlled, mHealth trial for developing mindfulness and emotional regulation in expectant couples |
| Study acronym | B³ |
| Study objectives | Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms. The goal of this intervention study is to learn if weekly recommendations to short, mobile app-based self-regulation exercises, combined with weekly feedback and reinforcement, can improve self-reported well-being of both mothers and fathers who are expecting their first child. This intervention takes place during pregnancy. The study involves 286 expectant couples (572 individuals) in a two-arm, cluster-randomized controlled trial with longitudinal observational follow-up until the child turns 6 months old. The study employs an adaptive intervention tailored to the expectant couples, using reinforcement learning and micro-randomization to deliver clinically designed audio coaching and educational modules from a mobile health (mHealth) app tailored to each couple. The study aims to answer the following main questions: • Does the intervention improve parents' depressive symptoms scores, using the Edinburgh Postnatal Depression Scale as a proxy? • Does the intervention improve parents' emotional regulation skills? |
| Ethics approval(s) |
Approved 11/04/2024, A*STAR Human Biomedical Research Office Institutional Review Board (2 Fusionopolis Way. Innovis #08-05, Singapore, 138634, Singapore; +65-64070100; hbro@a-star.edu.sg), ref: 2023-068 |
| Health condition(s) or problem(s) studied | Improvement of first-time parents' depressive symptoms, using Edinburgh Postnatal Depression Scale as a proxy |
| Intervention | The proposed study will be a two-arm, cluster-randomized, controlled trial with longitudinal observational follow-up. The active intervention comprises of customized, weekly recommendations of short (2-5 minute) audio clips featuring activities such as breathing exercises, meditation, mindful walking. These will be provided to adult participants (expectant couples). Couples enrolling in the study will randomly be allocated to either the control or intervention group by prespecified block sizes of 10. That is, a random number generator will be used to preset the assignments in groups of 10, such that every 10 consecutive enrolments will have exactly 5 controls and 5 interventions (1:1 allocation). While it is not possible to blind operational staff to assignments (different protocols to follow, highly unbalanced assignment), scheduling of enrolment visits will be done by different staff than those conducting the enrolment visits, and the assignment will only be made known to enrolment staff while conducting the visit itself and they will also not have access to the blocking and randomization algorithm. Participants in the control, no-intervention group will have access to a mobile app with similar functions as the participants in the intervention group, except that no personalized modules are given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. Participants in the intervention group will have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Participants will also be re-randomized weekly to different modules within the app. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. The intervention will take place throughout pregnancy, beginning at enrollment ( when the mother is less than 15 gestational weeks), and continuing until the child is born. As gestational duration varies among participants, the total intervention period will range approximately from 25 to 28 weeks, depending on the timing of recruitment and delivery. All study arms will be assessed up to 6 months after birth. |
| Intervention type | Behavioural |
| Primary outcome measure | Parents' level of depressive symptoms measured using the Edinburgh Postnatal Depression Scale, administered upon enrollment, once at 16-20 gestation weeks, once at 24-28 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. A composite outcome of the three postnatal EPDS measurements will be used as a primary outcome assessment. |
| Secondary outcome measures | Examining self-reported parental emotional regulation skills measured using the Cognitive Emotion Regulation Questionnaire, administered upon enrollment, once at 16-20 gestation weeks, once at 24-28 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. |
| Overall study start date | 30/03/2022 |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Healthy volunteer, Population, Resident |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target number of participants | 572 |
| Key inclusion criteria | Mothers: 1. 21–50 years of age 2. Less than 15 weeks of pregnancy, confirmed by ultrasonography upon enrolment 3. Singleton pregnancy 4. Nulliparous 5. Plan to deliver in Singapore 6. Proficient and able to respond to questionnaires in English 7. Intends for herself and her child to stay in Singapore for the next 2 years 8. Access to a smartphone 9. Willing to download the study app 10. Score of 7 or more in the Edinburgh Postnatal Depression Scale Fathers: 1. 21–75 years of age 2. Proficient and able to respond to questionnaires in English 3. Intends for himself and his child to stay in Singapore for the next 2 years 4. Access to a smartphone 5. Willing to download the study app |
| Key exclusion criteria | Mothers: 1. Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders 2. Currently on oral/IV steroids and/or thyroid medication 3. History of thyroid disease 4. Pregnant using assisted reproductive technologies 5. Multiple pregnancies 6. Currently enrolled in interventional randomised controlled trials 7. Responded "Yes, quite often" to EPDS item 10 ("The thought of harming myself has occurred to me") Fathers: 1. Currently enrolled in interventional randomised controlled trials |
| Date of first enrolment | 31/10/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Singapore
Study participating centre
MD11
#06-02
Singapore
117592
Singapore
Sponsor information
Research organisation
30 Medical Drive
Singapore
117609
Singapore
| Phone | +65-64070100 |
|---|---|
| research_affairs@a-star.edu.sg | |
| Website | https://www.a-star.edu.sg/ihdp |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The decision regarding the availability of individual participant data for sharing requires further discussions between the institutes and will be made available at a later date. |
Editorial Notes
29/10/2025: Trial's existence confirmed by A*STAR.
