Community Enabled Readiness for First 1000 Days Learning Ecosystem

Study Overview
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Brief Summary
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The CRADLE (Community-enabled Readiness-for-1000-Days Learning Ecosystem) initiative seeks to improve first-time families' self-efficacy in parenting and to tangibly impact factors in maternal and child care which will result in improved health of mother and child.

Detailed Description
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Title: CRADLE (Community enabled Readiness for first 1000-Days Learning Ecosystem) Project Introduction: The developmental origins of health and disease (DOHaD) is a concept that has emerged over the past 50 years, linking the state of health and risk from disease in early childhood and adult life. With increasing evidence in neuroscience of the critical window of the first 1000 days of life which has life- long impact on cognitive, behavioral, physical and mental health of an individual. In present society where new parents learned the skills from social media which are based on personal perception and not evidence. CRADLE (Community-enabled Readiness-for-1000-Days Learning Ecosystem) initiative seeks to improve first-time families' self-efficacy in parenting and to tangibly impact factors in maternal and child care which will result in improved health of mother and child. Hypothesis: Use of an integrated choice architecture in a self-learning eco-community, with calibrated nudges, and group interactions & interaction with midwives and individualised teleconferencing sessions in the first 1000-days for first-time families will improve parenting self-efficacy. Method: This will be an Interventional Cohort Study. Each ARM 250 subjects. ARM 1 : Routine care ARM 2 : Behavioral Intervention with nudges and Facebook interaction ARM 3 : Community Intervention with interaction with midwives and individualised teleconferencing sessions The follow up period will be from first contact till child reaches 2 years old Measurement. The investigators will quantify the impact of this initiative through measurements of specific health & nutrition domains & patient-reported outcome measures (see below) as well as participant satisfaction. The two key health morbidities the investigators are addressing are the overall health and mental wellness of first-time families as well as their metabolic health (ie, nutrition). Mother's Height and Weight (BMI) Child's Height and Weight (BMI) PROMIS Global-10 Scale Patient Health Questionaire-2 Edinburgh Postnatal Depression Scale Parental Sense Of Competency Scale Tool To Measure Parenting Self-Efficacy (TOPSE) Birth Satisfaction Scale Breastfeeding Self-Efficacy Scale Infant Feeding Questionnaire

Official Title
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Community Enabled Readiness for First 1000 Days Learning Ecosystem

Conditions
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Emotional Well-being of First-time Families, Nutritional Health of Mother and Child, Parenting Self-Efficacy for First-time Families, Experience of First-time Families

Intervention / Treatment
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* Behavioral: Arm 2:Behavioral Intervention with nudges & Facebook interaction
* Other: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-time mothers Be at least 17 years of age Is residing in Singapore for the next 3 years Understand English, or has a family member who is able to assist. Exclusion Criteria: 1. Has existing medical conditions such as chronic illnesses

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1: Routine Care<br>Participants will undergo routine care but take part in assessments. | |
| Active Comparator: Arm 2:Behavioral Intervention with nudges & Facebook<br>Participants will receive nudges and be enrolled in social media platform. | Behavioral: Arm 2:Behavioral Intervention with nudges & Facebook interaction<br>* Participants will receive nudges and be enrolled to Facebook group for self-learning.<br>|
| Active Comparator: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.<br>Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives. | Other: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.<br>* Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting self-efficacy | Parenting self-efficacy as assessed by the Tool to measure Parenting Self-Efficacy, which is domain-specific. | Up to 24 months of age, from 6 weeks after birth until 24 months of age | 
| Parenting self-efficacy | Parenting self-efficacy as assessed by the Parental Sense of Competence Scale, which is domain-general. | Up to 24 months of age, from 6 weeks after birth until 24 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health experience | Health Experience as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global10. | Up to 18 months of age, from first trimester in pregnancy until 18 months during the postnatal period | 
| Birth experience | Birth Experience as assessed by the Birth Satisfaction Scale - Revised. | At point of birth | 
| Mental wellness | Mental wellness as assessed by the Patient Health Questionnaire-2. | Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period | 
| Depressive symptoms | Depressive symptoms as assessed by the Edinburg Postnatal Depression Scale (EPDS). | Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period | 
| Maternal nutritional status | Maternal nutritional status as assessed based on weight status, i.e. weight gain and weight retention. | Through study completion, from first trimester in pregnancy up to 24 months during postnatal period | 
| Child nutritional status | Child nutritional status as assessed based on weight and height. | From birth until up to 24 months during postnatal period | 
| Breastfeeding self-efficacy | Breastfeeding self-efficacy as assessed by the Breastfeeding Self-Efficacy Score-Short Form. | From birth until up to 6 months during postnatal period | 
| Maternal feeding beliefs and practices | Maternal feeding beliefs and practices as assessed by the Infant Feeding Questionnaire. | At 18 months of age, at 18 months during postnatal period |