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Community Enabled Readiness for First 1000 Days Learning Ecosystem

Community Enabled Readiness for First 1000 Days Learning Ecosystem

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04275765
Acronym
CRADLE
Enrollment
750
Registered
2020-02-19
Start date
2020-06-15
Completion date
2022-09-30
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

BEHAVIORALArm 2:Behavioral Intervention with nudges & Facebook interaction

Participants will receive nudges and be enrolled to Facebook group for self-learning.

OTHERArm 3: Community Intervention with individualised teleconferencing sessions and phone calls.

Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Interventional study design

Eligibility

Sex/Gender
FEMALE
Age
17 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Parenting self-efficacyUp to 24 months of age, from 6 weeks after birth until 24 months of ageParenting self-efficacy as assessed by the Tool to measure Parenting Self-Efficacy, which is domain-specific.

Secondary

MeasureTime frameDescription
Health experienceUp to 18 months of age, from first trimester in pregnancy until 18 months during the postnatal periodHealth Experience as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global10.
Birth experienceAt point of birthBirth Experience as assessed by the Birth Satisfaction Scale - Revised.
Mental wellnessUp to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal periodMental wellness as assessed by the Patient Health Questionnaire-2.
Child nutritional statusFrom birth until up to 24 months during postnatal periodChild nutritional status as assessed based on weight and height.
Maternal nutritional statusThrough study completion, from first trimester in pregnancy up to 24 months during postnatal periodMaternal nutritional status as assessed based on weight status, i.e. weight gain and weight retention.
Breastfeeding self-efficacyFrom birth until up to 6 months during postnatal periodBreastfeeding self-efficacy as assessed by the Breastfeeding Self-Efficacy Score-Short Form.
Maternal feeding beliefs and practicesAt 18 months of age, at 18 months during postnatal periodMaternal feeding beliefs and practices as assessed by the Infant Feeding Questionnaire.
Depressive symptomsUp to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal periodDepressive symptoms as assessed by the Edinburg Postnatal Depression Scale (EPDS).

Countries

Singapore

Contacts

Primary ContactKee Chong Ng, MMed
ng.kee.chong@singhealth.com.sg63942301
Backup ContactJoyce Teo, BBus
joyce.teo.xy@kkh.com.sg63947137

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026