CRADLE: Community Enabled Readiness for First 1000 Days Learning Ecosystem

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04275765
Collaborator
(none)
750
1
3
27.5
27.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Arm 2:Behavioral Intervention with nudges & Facebook interaction
  • Other: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Interventional study designInterventional study design
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Community Enabled Readiness for First 1000 Days Learning Ecosystem
Actual Study Start Date :
Jun 15, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Tool to measure Parenting Self-Efficacy, which is domain-specific.

  2. 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

  1. 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.

  2. Birth experience [At point of birth]

    Birth Experience as assessed by the Birth Satisfaction Scale - Revised.

  3. 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.

  4. 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).

  5. 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.

  6. Child nutritional status [From birth until up to 24 months during postnatal period]

    Child nutritional status as assessed based on weight and height.

  7. 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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KK Women's and Children's Hospital Singapore Singapore 229899

Sponsors and Collaborators

  • KK Women's and Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ng Kee Chong, Senior Consultant, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT04275765
Other Study ID Numbers:
  • 201907-00050
First Posted:
Feb 19, 2020
Last Update Posted:
Nov 4, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 4, 2020