Community Enabled Readiness for First 1000 Days Learning Ecosystem

Emotional Well-being of First-time Families Clinical Trial

— CRADLE  

Official title:

Community Enabled Readiness for First 1000 Days Learning Ecosystem

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275765
• Other study ID #: 201907-00050
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2020
• Source: KK Women's and Children's Hospital
• Contact: Kee Chong Ng, MMed
• Phone: 63942301
• Email: ng.kee.chong[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Arm 2:Behavioral Intervention with nudges & Facebook interaction
Participants will receive nudges and be enrolled to Facebook group for self-learning.

Other:
• Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.
Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Birth experience	Birth Experience as assessed by the Birth Satisfaction Scale - Revised.	At point of birth
Secondary	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
Secondary	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
Secondary	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
Secondary	Child nutritional status	Child nutritional status as assessed based on weight and height.	From birth until up to 24 months during postnatal period
Secondary	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
Secondary	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

External Links

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