Clinical trial NCT04275765: Community Enabled Readiness for First 1000 Days Learning Ecosystem
Official title: Community Enabled Readiness for First 1000 Days Learning Ecosystem
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-19
Enrollment: 750
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study design
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Parenting self-efficacy
timeFrame: Up to 24 months of age, from 6 weeks after birth until 24 months of age
measure: Parenting self-efficacy
timeFrame: Up to 24 months of age, from 6 weeks after birth until 24 months of age
Secondary outcomes:
measure: Health experience
timeFrame: Up to 18 months of age, from first trimester in pregnancy until 18 months during the postnatal period
measure: Birth experience
timeFrame: At point of birth
measure: Mental wellness
timeFrame: Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period
measure: Depressive symptoms
timeFrame: Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period
measure: Maternal nutritional status
timeFrame: Through study completion, from first trimester in pregnancy up to 24 months during postnatal period
measure: Child nutritional status
timeFrame: From birth until up to 24 months during postnatal period
measure: Breastfeeding self-efficacy
timeFrame: From birth until up to 6 months during postnatal period
measure: Maternal feeding beliefs and practices
timeFrame: At 18 months of age, at 18 months during postnatal period
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Kee Chong Ng, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.