Emotional Well-being of First-time FamiliesCRADLENCT04275765
Community Enabled Readiness for First 1000 Days Learning Ecosystem
A study testing Arm 2:Behavioral Intervention with nudges & Facebook interaction and Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls. in people with Emotional Well-being of First-time Families and Nutritional Health of Mother and Child, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 17 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotional Well-being of First-time Families, Nutritional Health of Mother and Child, Parenting Self-Efficacy for First-time Families
- What is being tested?
- Arm 2:Behavioral Intervention with nudges & Facebook interaction and Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Jun 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First-time mothers
- Be at least 17 years of age
- Is residing in Singapore for the next 3 years
- Understand English, or has a family member who is able to assist.
Who cannot join
- 1. Has existing medical conditions such as chronic illnesses
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Kee Chong Ng, MMed, 63942301, ng.kee.chong@singhealth.com.sg
Joyce Teo, BBus, 63947137, joyce.teo.xy@kkh.com.sg
About this study
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.
Read the 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).
- Mother's Height and Weight (BMI)
- Child's Height and Weight (BMI)
- PROMIS Global-10 Scale
- Patient Health Questionaire-2
- Edinburgh Postnatal Depression Scale
- Parental Sense Of Competency Scale
- Tool To Measure Parenting Self-Efficacy (TOPSE)
- Birth Satisfaction Scale
- Breastfeeding Self-Efficacy Scale
- Infant Feeding Questionnaire
- 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
- Being tested
- Arm 2:Behavioral Intervention with nudges & Facebook interaction, Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 2:Behavioral Intervention with nudges & Facebook interactionBehavioural
Participants will receive nudges and be enrolled to Facebook group for self-learning.
Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.Other
Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Routine Care | No intervention | Participants will undergo routine care but take part in assessments. |
| Arm 2:Behavioral Intervention with nudges & Facebook | Active comparator | Participants will receive nudges and be enrolled in social media platform. Receives: Behavioral: Arm 2:Behavioral Intervention with nudges & Facebook interaction |
| Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls. | Active comparator | Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives. Receives: Other: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting self-efficacy
Parenting self-efficacy as assessed by the Tool to measure Parenting Self-Efficacy, which is domain-specific.
Measured: Up to 24 months of age, from 6 weeks after birth until 24 months of age
Parenting self-efficacy
Parenting self-efficacy as assessed by the Parental Sense of Competence Scale, which is domain-general.
Measured: Up to 24 months of age, from 6 weeks after birth until 24 months of age
Secondary outcomes (8)
Health experience
Health Experience as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global10.
Measured: Up to 18 months of age, from first trimester in pregnancy until 18 months during the postnatal period
Birth experience
Birth Experience as assessed by the Birth Satisfaction Scale - Revised.
Measured: At point of birth
Mental wellness
Mental wellness as assessed by the Patient Health Questionnaire-2.
Measured: Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period
Depressive symptoms
Depressive symptoms as assessed by the Edinburg Postnatal Depression Scale (EPDS).
Measured: Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period
Maternal nutritional status
Maternal nutritional status as assessed based on weight status, i.e. weight gain and weight retention.
Measured: Through study completion, from first trimester in pregnancy up to 24 months during postnatal period
Child nutritional status
Child nutritional status as assessed based on weight and height.
Measured: From birth until up to 24 months during postnatal period
Breastfeeding self-efficacy
Breastfeeding self-efficacy as assessed by the Breastfeeding Self-Efficacy Score-Short Form.
Measured: From birth until up to 6 months during postnatal period
Maternal feeding beliefs and practices
Maternal feeding beliefs and practices as assessed by the Infant Feeding Questionnaire.
Measured: At 18 months of age, at 18 months during postnatal period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start15 Jun 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional Well-being of First-time FamiliesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study design
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ng Kee Chong, KK Women's and Children's Hospital
- Investigators
- Kee Chong Ng, MMed, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275765
- Sponsor's protocol ID
- 201907-00050
- Acronym
- CRADLE
- Status last verified
- Nov 2020
- First submitted
- 20 Jan 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to IPD will be limited to the project study team only.
Publications
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.
PubMed 33676560
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Enabled Readiness for First 1000 Days Learning Ecosystem
- ClinicalTrials.gov ID
- NCT04275765
- Acronym / sponsor ID
- CRADLE / 201907-00050
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- Mother's Height and Weight (BMI)
- Child's Height and Weight (BMI)
- PROMIS Global-10 Scale
- Patient Health Questionaire-2
- Edinburgh Postnatal Depression Scale
- Parental Sense Of Competency Scale
- Tool To Measure Parenting Self-Efficacy (TOPSE)
- Birth Satisfaction Scale
- Breastfeeding Self-Efficacy Scale
- Infant Feeding Questionnaire
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional study design
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Routine Care | No intervention | –Participants will undergo routine care but take part in assessments. |
| Arm 2:Behavioral Intervention with nudges & Facebook | Active comparator | Behavioral: Arm 2:Behavioral Intervention with nudges & Facebook interactionParticipants will receive nudges and be enrolled in social media platform. |
| Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls. | Active comparator | Other: Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives. |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- First-time mothers
- Be at least 17 years of age
- Is residing in Singapore for the next 3 years
- Understand English, or has a family member who is able to assist.
Key exclusion criteria (1 listed)
- 1. Has existing medical conditions such as chronic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 2:Behavioral Intervention with nudges & Facebook interactionParticipants will receive nudges and be enrolled to Facebook group for self-learning. | Behavioural | Arm 2:Behavioral Intervention with nudges & Facebook |
| 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. |
Primary outcome
Parenting self-efficacy
Time frame: 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.
Parenting self-efficacy
Time frame: 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.
8 secondary outcomes
Health experience
Time frame: Up to 18 months of age, from first trimester in pregnancy until 18 months during the postnatal period
Birth experience
Time frame: At point of birth
Mental wellness
Time frame: Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period
Depressive symptoms
Time frame: Up to 6 months of age, from first trimester in pregnancy up to 6 months during postnatal period
Maternal nutritional status
Time frame: Through study completion, from first trimester in pregnancy up to 24 months during postnatal period
Child nutritional status
Time frame: From birth until up to 24 months during postnatal period
Breastfeeding self-efficacy
Time frame: From birth until up to 6 months during postnatal period
Maternal feeding beliefs and practices
Time frame: At 18 months of age, at 18 months during postnatal period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 33676560Loy 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.
- PROMIS GLOBAL HEALTHLink provided by the sponsor.
- THE PATIENT HEALTH QUESTIONAIRE-2 (PHQ-2)Link provided by the sponsor.
- EDINBURGH POSTNATAL DEPRESSION SCALE (EPDS)Link provided by the sponsor.
- PARENTAL SENSE OF COMPETENCY SCALE (PSOC)Link provided by the sponsor.
- TOPSE Tool to measure Parenting Self-EfficacyLink provided by the sponsor.
- BREASTFEEDING SELF-EFFICACY SCORE- SHORT FORMLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to IPD will be limited to the project study team only.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kee Chong Ng, MMed principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 2:Behavioral Intervention with nudges & Facebook interaction and Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls. in people with Emotional Well-being of First-time Families and Nutritional Health of Mother and Child, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kee Chong Ng, MMed (63942301, ng.kee.chong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting self-efficacy (time frame: Up to 24 months of age, from 6 weeks after birth until 24 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04275765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.