Community Enabled Readiness for First 1000 Days Learning Ecosystem
NCT ID: NCT04275765
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
750 participants
INTERVENTIONAL
2020-06-15
2022-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1: Routine Care
Participants will undergo routine care but take part in assessments.
No interventions assigned to this group
Arm 2:Behavioral Intervention with nudges & Facebook
Participants will receive nudges and be enrolled in social media platform.
Arm 2:Behavioral Intervention with nudges & Facebook interaction
Participants will receive nudges and be enrolled to Facebook group for self-learning.
Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.
Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.
Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.
Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.
Interventions
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Arm 2:Behavioral Intervention with nudges & Facebook interaction
Participants will receive nudges and be enrolled to Facebook group for self-learning.
Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.
Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.
Eligibility Criteria
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Inclusion Criteria
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
17 Years
FEMALE
Yes
Sponsors
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KK Women's and Children's Hospital
OTHER_GOV
Responsible Party
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Ng Kee Chong
Senior Consultant
Principal Investigators
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Kee Chong Ng, MMed
Role: PRINCIPAL_INVESTIGATOR
KK Women's and Children's Hospital
Locations
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KK Women's and Children's Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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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
Other Identifiers
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201907-00050
Identifier Type: -
Identifier Source: org_study_id