Community Enabled Readiness for First 1000 Days Learning Ecosystem (CRADLE)

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.

Study Overview

• Status: Unknown
• Conditions: 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: Behavioral: Arm 2:Behavioral Intervention with nudges & Facebook interaction; Other: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.

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 Type: Interventional
• Enrollment (Anticipated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kee Chong Ng, MMed; Phone Number: 63942301; Email: ng.kee.chong@singhealth.com.sg
• Study Contact Backup: Name: Joyce Teo, BBus; Phone Number: 63947137; Email: joyce.teo.xy@kkh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • Recruiting
    • KK Women's and Children's Hospital
    • Contact: Kee Chong Ng, MMed; Phone Number: 63942301; Email: ng.kee.chong@singhealth.com.sg
    • Contact: Joyce Teo, BBus; Phone Number: 63947137; Email: joyce.teo.xy@kkh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Kee Chong Ng, MMed, KK Women's and Children's Hospital

Publications and helpful links

General Publications

• Loy SL, Thilagamangai, Teo J, Chan SW, Razak NKA, Chay OM, Ng KC. A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial. Trials. 2021 Mar 6;22(1):191. doi: 10.1186/s13063-021-05144-5.

Helpful Links

• PROMIS GLOBAL HEALTH
• THE PATIENT HEALTH QUESTIONAIRE-2 (PHQ-2)
• EDINBURGH POSTNATAL DEPRESSION SCALE (EPDS)
• PARENTAL SENSE OF COMPETENCY SCALE (PSOC)
• TOPSE Tool to measure Parenting Self-Efficacy
• BREASTFEEDING SELF-EFFICACY SCORE- SHORT FORM
• BIRTH SATISFACTION SCALE-REVISED
• INFANT FEEDING QUESTIONNAIRE

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 201907-00050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to IPD will be limited to the project study team only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No