Community Enabled Readiness for First 1000 Days Learning Ecosystem

Not Applicable

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

• Registration Number: NCT04275765
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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

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).

1. Mother's Height and Weight (BMI)

2. Child's Height and Weight (BMI)

3. PROMIS Global-10 Scale

4. Patient Health Questionaire-2

5. Edinburgh Postnatal Depression Scale

6. Parental Sense Of Competency Scale

7. Tool To Measure Parenting Self-Efficacy (TOPSE)

8. Birth Satisfaction Scale

9. Breastfeeding Self-Efficacy Scale

10. Infant Feeding Questionnaire

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2020-06-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

1. First-time mothers
2. Be at least 17 years of age
3. Is residing in Singapore for the next 3 years
4. Understand English, or has a family member who is able to assist.

Exclusion Criteria

1. Has existing medical conditions such as chronic illnesses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parenting self-efficacy	Up to 24 months of age, from 6 weeks after birth until 24 months of age	Parenting self-efficacy as assessed by the Parental Sense of Competence Scale, which is domain-general.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore