Clinical trial NCT05207059: Healthy Early Life Moments in Singapore
Official title: Healthy Early Life Moments in Singapore
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Disease
Mental Health Wellness 1
Lifestyle Risk Reduction
Maternal Obesity
Keywords: Obesity
Mental health
Lifestyle intervention
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Lien Foundation
First posted: 2022-01-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HELMS is conceptualised as a single-arm implementation pilot trial, where lifestyle interventions are implemented in overweight or obese women from preconception to pregnancy and postpartum periods. We will follow both mother and child up to 18 months after delivery.
Primary purpose: PREVENTION

Brief summary: This study aims to assess whether an integrated continuum of care from the preconception period, across maternity until the first 18 months of life, can promote maternal metabolic and mental health, as well as offspring health, among overweight and obese women.

Detailed description: Maternal Child Health (MCH) in Singapore is currently entering a new phase to address the twin challenges; a burgeoning (i) Metabolic and (ii) Mental Health Challenge for Singapore which have shown to have adverse effects on childbearing and child outcomes. To tackle these challenges, we are establishing a new Model-of-Care (MOC) with a life-course approach at KK Women's and Children's Hospital (KKH) through the Healthy Early Life Moments in Singapore (HELMS) cohort. Over the course of five years, HELMS will enroll 500 overweight or obese women aged 21-40 years planning for pregnancy, with an estimated 170 completing their pregnancies where they will be followed for another 18 months as a mother-child dyad.

HELMS leverages on building a healthy mental model of life-course events through preconception to postpartum life. Components of intervention will focus on preconception-pregnancy-postpartum care and lifestyle guidance on diet, physical activity, emotion and sleep, complemented by health nudges to promote sustainable change. Various questionnaires and testing will be carried out at relevant time points. Biosamples including blood, cord blood and stool will be collected.

Through the application of HELMS, there is potential to improve metabolic and mental health, break vicious transgenerational cycles of obesity transmission and promote virtuous life cycles of health in the population.

Eligibility criteria: Inclusion Criteria:

1. Women aged 21-40 years
2. BMI 25-40 kg/m2
3. Intention to reside in Singapore for the next 4 years
4. Chinese, Malay, Indian or any combination of these 3 ethnic groups
5. Planning to conceive within 1 year
6. Able to understand English
7. Able to provide written, informed consent

Exclusion Criteria:

1. Currently pregnant
2. Known type 1 or type 2 diabetes
3. On any anticonvulsant medication in the past 1 month
4. On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron)
5. On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month
6. On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene/ Letrozole in the past 1 month
7. On HIV or Hepatitis B or C medication in the past 1 month.

Primary outcomes:
measure: Pregnancy rate
timeFrame: Up to 12 months
measure: Maternal metabolic health
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal mental health
timeFrame: Up to 26 months, between preconception, pregnancy and 4 months postpartum
Secondary outcomes:
measure: Fecundability
timeFrame: Up to 12 months, between dates of last menstrual period at recruitment and before conception (for pregnant women) or last follow-up call (for non-pregnant women)
measure: Female sexual function
timeFrame: Up to 3 months, between date of recruitment and 3 months preconception follow-up
measure: Pregnancy loss rate
timeFrame: Up to 42 weeks, between date of conception and date of delivery
measure: Live birth rates
timeFrame: Up to 42 weeks, between date of conception and date of delivery
measure: Maternal lipid levels
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal glycaemic marker - plasma glucose
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal glycaemic marker - HbA1c
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal glycaemic marker - C-peptide
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal glycaemic markers - Insulin
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal glucose tolerance status
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal blood pressure
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal heart rate
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal body weight
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal body weight status
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal body fat distribution
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal abdominal fat
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal body composition
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal body fat mass
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal visceral fat
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal body lean mass
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal nutrient intake
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal food intake
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal food intakes
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal dietary pattern
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal food timing
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal eating episodes
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal dietary behaviour - 6P
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal dietary behaviour - TFEQ
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal micronutrient status
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal physical activity level - self assessment
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal physical activity
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal sedentary behaviour - self assessment
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal sedentary behaviour
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal sleep - PSQI
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal sleep
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal emotional wellbeing
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal ocular health
timeFrame: Up to 21 months, from preconception until 36 weeks gestation
measure: Maternal ocular health
timeFrame: Up to 21 months, from preconception until 36 weeks gestation
measure: Maternal personality trait
timeFrame: At preconception
measure: Duration of gestation
timeFrame: Up to 42 weeks, between estimated date of conception from menstrual and ultrasound scan and date of delivery
measure: Number of participants with gestational diabetes
timeFrame: Up to 20 weeks, between 12 and 32 weeks gestation
measure: Number of participants with hypertensive disorders of pregnancy
timeFrame: Up to 42 weeks, between date of conception and date of delivery
measure: Mode of labour onset, course of delivery and delivery outcomes
timeFrame: Delivery
measure: Maternal pain
timeFrame: Up to 5 months, between 32 weeks gestation and 6-8 weeks post-delivery
measure: Antenatal, perinatal and postnatal complications
timeFrame: Up to 50 weeks, between date of conception and up to 8 weeks postpartum
measure: Neonatal complications and admission to neonatal care facilities
timeFrame: Up to 4 weeks, between date of delivery and 4 weeks post-delivery
measure: Offspring body weight
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring body size at birth
timeFrame: At birth
measure: Offspring body length
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring head circumference
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Intrauterine growth of foetus
timeFrame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
measure: Offspring feeding
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring gut microbiome
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Maternal gut microbiome
timeFrame: Up to 24 months, between preconception, pregnancy and 2 months postpartum
measure: Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Acceptability and adherence levels
timeFrame: Up to 40 months, at preconception, pregnancy and 18 months postpartum
measure: Satisfactory level of participants with the HELMS program
timeFrame: Up to 40 months, at preconception, pregnancy and 18 months postpartum
Other outcomes:
measure: Health economics analysis of the HELMS program
timeFrame: Composite analysis between preconception visit which is up to 12 months before pregnancy and until infant age 18 months
measure: Maternal general health and wellbeing
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Offspring health and general wellbeing
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring metabolomic profile
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring genomic profile
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring epigenetic profile
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring biochemical profile
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring metabolic profile
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring immunological profile
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Offspring molecular profile
timeFrame: Up to 18 months, from birth to infant age 18 months
measure: Maternal metabolomic profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal genomic profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal epigenetic profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal temperature
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal biochemical profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal metabolic profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal immunological profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Maternal molecular profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal body weight
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal body weight status
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal body fat distribution
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal abdominal fat
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal body composition
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal body fat mass
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal body lean mass
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal body visceral fat
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal health and general well-being - self assessment
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal health and general well-being
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal immunological profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal biochemical profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal metabolic profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Paternal molecular profile
timeFrame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
measure: Breast milk macronutrient profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Breast milk micronutrient profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Breast milk immune factor profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Breast milk epigenetic profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Breast milk biochemical profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Breast milk metabolic profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Breast milk microbiome profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Breast milk molecular profile (subsample)
timeFrame: Up to 1 year, between date of delivery and 1 year postpartum
measure: Maternal transcriptomics
timeFrame: Up to 36 months, between preconception, pregnancy and 1 year postpartum
measure: Infant transcriptomics
timeFrame: Up to 36 months, between preconception, pregnancy and 1 year postpartum
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Jerry Chan, MB BCh BaO MA FRCOG PhD
role: PRINCIPAL_INVESTIGATOR
References: