Trial design
CRADLE is conceptualised as a three-arm, parallel-group, non-blinded randomised control trial (RCT). The allocation ratio of the two intervention groups to the control group is 1:1:1. Pregnant women preparing for their first-time families are recruited in the first trimester, randomly allocated into the three arms and followed until two years post-delivery (Fig. 2). The three arms comprise: 1) standard routine care; 2) behavioural nudges (text messages) along with the use of a social media platform; 3) midwife-led continuity care involving home visits. The protocol has followed the SPIRIT guidelines (see Additional file 1). The trial registration number of the study is ClinicalTrials.gov NCT 04275765.
Recruitment
The study is conducted at the KK Women’s and Children’s Hospital (KKH), Singapore. KKH houses the largest Obstetrics and Gynaecology department in Singapore, with over 10,000 (≈30%) live births recorded annually. In this study, we will recruit up to 750 pregnant women in their first trimester from the antenatal clinics of KKH. Recruitment brochures, posters and banners that contain general information and selection criteria of the study will be placed at different locations, such as hospital lifts and clinics. Interested women will self-contact the study team by email or phone, or to be referred by doctors or nurses.
Trained research staff will assess women’s eligibility based on the following criteria: first-time mother, aged 17 years and above, going to reside in Singapore for the next three years, absence of pre-existing chronic medical conditions and/ or able to understand English. Eligible participants will sign the written informed consents and be randomised via the electronic randomization list into one of the three arms. Recruitment is projected to begin in June 2020 and end in May 2021.
Study procedures
After randomisation, research staff will perform baseline assessment on socio-demography and health status. All participants will be followed-up in the third trimester, at birth, 6-week, 6-, 12-, 18- and 24-month post-delivery. Depending on the follow-up time-point, every participant is required to complete few sets of online questionnaires for assessments on PSE, health and birth experience, mental wellness and feeding practice. Maternal and child anthropometric measures including weight and height will also be assessed. Research staff will retrieve medical records for information on obstetric and delivery outcomes. Study measures and questionnaires used are presented in Table 1. Throughout the study period, participants who experience loss of pregnancy, perinatal demise, congenital abnormalities in offspring, serious medical events in mother/ child, unable to comply with study protocol or wish to discontinue their participation will be withdrawn from the study. For participants who withdraw from the study, consent will be sought to retain and analyse their data until the withdrawal time-point.
Table 1 Data collection and study instruments
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First trimester
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Third trimester
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Birth
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6 weeks
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6 months
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12 months
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18 months
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24 months
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Informed consent
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√
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Randomization arm
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√
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Socio-demography
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Age
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√
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Ethnicity
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√
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Family structure
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√
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Education
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√
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Health and birth experience
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PROMIS Global-10 scale*
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√
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√
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√
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√
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Birth Satisfaction Scale-Revised*
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√
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Mental wellness
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Patient Health Questionaire-2*
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√
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√
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√
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√
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Edinburgh Postnatal Depression Scale
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√
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√
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√
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√
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Nutrition
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Breastfeeding success
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√
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√
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√
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Breastfeeding confidence
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√
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√
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Breastfeeding Self-Efficacy Score-Short Form*
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√
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√
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√
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Infant Feeding Questionnaire
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√
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Maternal and child weight/ height
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√
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√
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√
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√
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√
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√
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√
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√
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Parenting self-efficacy
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TOPSE*
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√
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√
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√
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√
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√
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Parental Sense of Competence Scale*
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√
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√
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√
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√
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√
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Medical records retrieval
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Obstetric and delivery outcomes
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√
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*From the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set of Outcome Measures for Pregnancy and Childbirth
PROMIS, Patient Reported Outcomes Measurement Information System; TOPSE, Tool to measure Parenting Self-Efficacy
The intervention
Arm 2 and Arm 3 interventions are designed based on the framework that can eventually lead to a self-learning ecosystem in the community to improve early PSE and health outcomes for first-time families.
In Arm 2, we will interact with the participants virtually. The participants will receive weekly mobile messages on important information related to antenatal care, breastfeeding, infant care, child growth and development, and postpartum care. These messages are targeted and time specific according to stages in the pregnancy and early childhood. There were designed by the study team’s health experts as reference to the Ready4K text messaging programme [31], serving as nudges to influence behaviour and guide first-time families in their pregnancy and early parenting journey. In order to create an interactive and sharing environment with peer support, participants will be enrolled automatically to a private social media platform group, where they are encouraged to share information, post photos and interact with each other. More detailed health information on relevant topics are available in the social media platform to encourage self-learning. Participants can post any query on health concern in their first 1000 days, which will be addressed by the study team’s experts. This is a restricted and by-invitation-only social media forum. The research staff will monitor the contents to ensure this sharing platform remain true to supporting these first-time families. We envision that motivated participants will be empowered and eventually, emerge as chat group leaders in this platform.
In Arm 3, we will embed a face-to-face approach by conducting midwife-led continuity care involving home visits. Participants will be encountered by midwives who interact with them at various time points throughout the study. During pregnancy, one session that lasts for 15-20 minutes is held in the antenatal clinic per trimester. Any question pertaining to pregnancy or childbirth can be clarified with the midwife. During post-delivery, the same midwife will perform home visits at 1- and 2-week postpartum (45-60 minutes per visit), and call to check for progression at 6-week, 3- and 6-month postpartum. Participants can discuss any concern relating to postpartum health, infant care, breastfeeding, child growth and development with the midwife. In the case when there is uncertainty about queries asked by the participant, advice from the study team’s health experts will be sought. We envision that motivated participants will be empowered and eventually, emerge as support volunteers assisting in midwifery care delivery in the community.
Outcome measures
We quantify the impact of interventions by measuring PSE in first-time mothers, along with specific health outcomes.
Primary outcome
The primary outcome of this RCT is PSE, measured using the Tool to measure Parenting Self-Efficacy (TOPSE) and the Parental Sense of Competence Scale (PSOC) at 6-week as the primary endpoint, follow by 6-, 12-, 18- and 24-month post-delivery. Both domain-specific (TOPSE) and domain-general (PSOC) self-efficacy measures will be used to evaluate any difference in outcome evaluations between two assessment tools operating at different levels of specificity [8].
The TOPSE is a multidimensional, self-report measure designed to assess parents’ perceived ability to parent their children, which took into account the views and experience of parents from a range of cultural and social backgrounds [36, 37]. The theoretical underpinning of TOPSE is based on self-efficacy theory developed by Bandura [38, 39]. It consists of 48 items which are divided into eight subsections: 1) emotion and affection, 2) play and enjoyment, 3) empathy and understanding, 4) control, 5) discipline and setting boundaries, 6) pressures, 7) self-acceptance, and 8) learning and knowledge. Participants will be requested to rate items using a 11-point Likert scale ranging from 0 (completely disagree) to 10 (completely agree). The higher the score, the higher the level of PSE.
The PSOC is a domain-general, self-report measure designed to measure parents’ satisfaction with parenting and their self-efficacy in the parenting role [40]. It consists of 17 items scored on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The higher the score, the higher the level of parenting satisfaction and self-efficacy.
Secondary outcomes
Secondary outcomes include health and birth experience, mental wellness and nutritional outcomes, assessed using validated patient reported outcome measurements, including the use of the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set of Outcome Measures for Pregnancy and Childbirth [41] and by anthropometric measures. Time points of assessment and ICHOM tools are indicated in Table 1.
Health experience will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 [42]. The instrument consists of 10 items representing general health, physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Nine of the 10 items are scored on a 5-point Likert scale ranging from 1 (poor/ not at all) to 5 (excellent/ completely). The pain – 10th item, is scored from 0 (no pain) to 10 (worst imaginable pain).
Birth experience will be assessed using the Birth Satisfaction Scale-Revised [43]. The instrument measures women’s perceptions on quality of care provision, women’s personal attributes and stress experienced during labour. It consists of 10 items rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Mental wellness will be assessed using the Patient Health Questionnaire-2 (PHQ-2) and the Edinburg Postnatal Depression Scale (EPDS). The PHQ-2 consists of 2 items rated on a 4-point Likert scale from 0 (not all all) to 3 (nearly every day), to screen for depression as a first step approach [44]. EPDS will be used when a woman scores a three or above on the PHQ-2, in order to further assess depressive symptoms in details. Although EPDS was originally designed to measure postnatal depression [45], it has been shown to be valid in assessing antenatal depression [46]. It consists of 10 items rated on a 4-point Likert scale, ranging from 0 (as much as I always could) to 3 (not at all).
Nutritional outcomes will be assessed based on breastfeeding and infant feeding practices, as well as anthropometric measures. We will evaluate breastfeeding in terms of breastfeeding success, breastfeeding confidence and breastfeeding self-efficacy. Breastfeeding success is measured according to feeding mode in the past seven days, with options of ‘only breast milk’, ‘combination of breast milk, formula and/ or water’, and ‘only formula, water or other liquids but not breast milk.’ We measure level of breastfeeding confidence based on a 5-point Likert scale from 1 (not at all) to 5 (very confident). We use the Breastfeeding Self-Efficacy Score-Short Form to assess maternal confidence in her ability to breastfeed her new baby [47]. The instrument consists of 14 items rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (very confident). We will also assess maternal feeding beliefs and practices using the Infant Feeding Questionnaire [48]. It is a 28-item questionnaire rated on a 5-point Likert scale, ranging from 1 (never/ disagree a lot) to 5 (always/ agree a lot). Nutritional status of both mother and child will be assessed throughout the study period, by evaluating maternal weight status across pregnancy and during postpartum, and child growth over the first two years, i.e. weight and length.
Sample size
Based on a previous parenting programme in childhood, a moderate effect (d=0.4) on PSE was reported [49]. We postulate that with our early interventions, a difference of d=0.35 in the overall TOPSE (primary outcome) score between intervention and control arms will be detected. In order to achieve a power of at least 80% with a two-sided significance level at 5%, a total of 150 participants are required for each arm. Assuming a dropout rate of 66% during the first 1000-day follow-up, the necessary sample size is 250 participants per arm, resulting in a total of 750 participants for three arms.
Statistical analysis
We will analyse the data according to the intention-to-treat principle, i.e. all participants who were assigned to a condition. Differences in outcomes across three arms at each time-point will be analysed using univariate ANVOVA. We will use linear regression mixed models to test the effects of interventions on outcomes across time-point. The missing data will be managed using multiple imputation techniques. Additionally, we will perform a priori sensitivity analysis for complete cases, i.e. participants with complete follow-up and data. There are no formal planned interim analyses of the primary outcome, but progress reports on all data issues will be presented to investigators of the study team. Across analyses, baseline characteristics (e.g. age, ethnicity, education) and measures will be controlled for to avoid their influences on the effectiveness of the intervention. The level of statistical significance will be set at 0.05 (two-tailed) and 95% confidence intervals will be calculated.
Quality control
Research staff who are responsible to recruit and follow-up participants received training on recruitment approach, informed consent taking, randomisation procedure, online questionnaires management, mobile messages (nudges) and reminders deliveries. Midwives received special training on midwifery home care service. Monthly meetings will be held with investigators and/ or project manager to review study procedures, recruitment strategy, participants’ feedback and collected data. An annual report on study progress will be prepared. The study will be audited by an independent party annually.
Data monitoring
All data will be anonymised. Participants’ identifiers will be kept separately in a password protected file. Electronic data will be managed using an online data capture tool. We will set up a data monitoring team to perform data checking on the completeness, errors and outliers. The data checking process will be carried out on a quarterly basis, follow by a meeting with investigators to review the data with issues. Paper documents will be kept in a locked cabinet and electronic data will be stored on password-protected computers or hard-disk drives which can only be accessed by research team members. All records will be maintained for at least 6 years after completing the study.
Patient and public involvement
The research questions, study design, exposure and outcome measures were determined based on a discussion with health experts (clinicians, nurses and researchers) in maternal and child care. Although participants did not directly contribute to the development of research questions and the study design, their needs, preferences and participation burden were considered throughout the process. The results of the study will be disseminated to participants at their request, after the study is completed.
Ethics and dissemination
Participants will sign a written informed consent after full disclosure and explanation of the study purpose and procedure. In the event of any new information or change in the study protocol that may be relevant to their willingness to continue the study, research staff will contact the participants in timely manner to seek for further consents if required. Participants will be informed that the use of nudges, social media and community midwife care are not yet proven to be a standard care for first-time parents from pregnancy to two years post-delivery. The use of these approaches are solely for research purpose. We expect no adverse health effect from the interventions.
Main findings of this study will be published in peer-reviewed international journals. Presentations of the study results will also be carried out in symposia, seminars and conferences. If the interventions are found to produce a positive impact, we will consider a media release to publicise the research findings.