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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
500
The HELMS life-course Interventions, namely 4S ('Screening', 'Size', 'Supplementation' and 'Specific case management'), are developed to deliver care throughout the journey from preconception to postpartum periods. Screening involves health and risk assessments through physical and biomarker measurements, as well as emotion and sleep evaluations for mother, and developmental assessment for children. Body Size management encompasses education on weight status awareness and mother-child health implications, both mother-child weight tracking, healthy eating and physical activity guidance. Supplementation includes multi-micronutrient, vitamin D, calcium and/or Docosahexaenoic acid (DHA) supplements, which is phase-specific for mother, and vitamin D drops supplement for child. Specific case management comprises preconception sexual health and function management, pregnancy symptoms management, postpartum recovery management, infant growth monitoring and feeding management.
KK Women's and Children's Hospital
Singapore, Singapore
Pregnancy rate
Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages
Time frame: Up to 12 months
Maternal metabolic health
Evaluated by metabolic syndrome criteria
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal mental health
Measured by Edinburgh Postnatal Depression Scale, scored between 0 to 30, with a higher score being suggestive of depression
Time frame: Up to 26 months, between preconception, pregnancy and 4 months postpartum
Fecundability
Measured by time to pregnancy in total discrete cycles at risk of pregnancy
Time frame: 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)
Female sexual function
Measured by Female Sexual Function Index, with a higher score being suggestive of better sexual function
Time frame: Up to 3 months, between date of recruitment and 3 months preconception follow-up
Pregnancy loss rate
Based on ultrasound scan and medical records, in percentage
Time frame: Up to 42 weeks, between date of conception and date of delivery
Live birth rates
Based on ultrasound scan and medical records, in percentage
Time frame: Up to 42 weeks, between date of conception and date of delivery
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Maternal lipid levels
Including total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, in mmol/L
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - plasma glucose
Measured by plasma glucose levels, in mmol/L
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - HbA1c
Measured by HbA1c, in percentage
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - C-peptide
Measured by C-peptide, in SI unit
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic markers - Insulin
Measured by serum insulin, in SI unit
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glucose tolerance status
Measured by Oral Glucose Tolerance Test (OGTT), in mmol/L
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal blood pressure
Measured by blood pressure device for systolic and diastolic pressures in mmHg
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal heart rate
Measured by blood pressure device or sensor in beats per minutes
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body weight
Measured by weighing scale in kilograms
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body weight status
Determined by body mass index based on weight (kg) /height (m)2
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body fat distribution
Determined from waist hip circumferences in centimeters
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal abdominal fat
Determined from waist hip circumferences in ratio
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body composition
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body fat mass
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal visceral fat
Determined from body fat analysis in volumes
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body lean mass
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal nutrient intake
Measured by food diary and/or food frequency questionnaire in SI units of respective nutrients
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal food intake
Measured by food diary and/or food frequency questionnaire in serving sizes
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal food intakes
Measured by food diary and/or food frequency questionnaire in grams
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal dietary pattern
Measured by food diary and/or food frequency questionnaire using factor loading analysis
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal food timing
Measured by food diary in time phase
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal eating episodes
Measured by food diary in eating frequency
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal dietary behaviour - 6P
Measured by 6P Questionnaire based on each factor in the questionnaire
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal dietary behaviour - TFEQ
Measured by Three Factor Eating Questionnaire, based on the scores from each category
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal micronutrient status
Micronutrient panel from plasma or breastmilk such as 1-carbon metabolites, vitamin D and E, expressed in SI units of respective micronutrients
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal physical activity level - self assessment
Measured by International Physical Activity Questionnaire, with a higher score suggesting higher physical activity level
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal physical activity
Measured by accelerometer and/or digital sensor, in respective SI units
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal sedentary behaviour - self assessment
Measured by sedentary behaviour questionnaire, in hours and minutes per day, with longer duration suggestive of greater sedentary behaviour
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal sedentary behaviour
Measured by accelerometer and/or digital sensor, in respective SI units
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal sleep - PSQI
Measured by Pittsburgh Sleep Quality Index, scored from 0-21, with higher score suggestive of poor sleep quality
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal sleep
Measured by accelerometer and/or digital sensor, in respective SI units
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal emotional wellbeing
Measured by questionnaires
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal ocular health
Measured by retinal vessel characteristics (including vessel caliber, geometric assessment and vasoreactivity)
Time frame: Up to 21 months, from preconception until 36 weeks gestation
Maternal ocular health
Measured by retinal and choroidal characteristics using three-dimensional volumetric (OCT-A) imaging systems
Time frame: Up to 21 months, from preconception until 36 weeks gestation
Maternal personality trait
Measured by M5-50 questionnaire, with classification into respective personality types
Time frame: At preconception
Duration of gestation
Defined as the length of pregnancy, in months and days
Time frame: Up to 42 weeks, between estimated date of conception from menstrual and ultrasound scan and date of delivery
Number of participants with gestational diabetes
Determined by oral glucose tolerance test during pregnancy
Time frame: Up to 20 weeks, between 12 and 32 weeks gestation
Number of participants with hypertensive disorders of pregnancy
Including pregnancy-induced hypertension and pre-eclampsia/eclampsia from questionnaire and/or retrieved from medical records
Time frame: Up to 42 weeks, between date of conception and date of delivery
Mode of labour onset, course of delivery and delivery outcomes
From questionnaire and/or retrieved from medical records, reported in percentages
Time frame: Delivery
Maternal pain
Measured by pain questionnaire
Time frame: Up to 5 months, between 32 weeks gestation and 6-8 weeks post-delivery
Antenatal, perinatal and postnatal complications
From questionnaire and/or retrieved from medical records, reported in percentages
Time frame: Up to 50 weeks, between date of conception and up to 8 weeks postpartum
Neonatal complications and admission to neonatal care facilities
From questionnaire and/or retrieved from medical records, reported in percentages
Time frame: Up to 4 weeks, between date of delivery and 4 weeks post-delivery
Offspring body weight
Weight measured in grams
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring body size at birth
Adjusted for gestational age and sex, expressed in percentile
Time frame: At birth
Offspring body length
Measured in centimeters
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring head circumference
Measured in centimeters
Time frame: Up to 18 months, from birth to infant age 18 months
Intrauterine growth of foetus
As assessed by antenatal serial ultrasound scans to determine head and abdominal circumference, femur length and estimated foetal weight
Time frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Offspring feeding
Measured types of feeding using questionnaires
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring gut microbiome
Measured from stool samples
Time frame: Up to 18 months, from birth to infant age 18 months
Maternal gut microbiome
Measured from stool samples
Time frame: Up to 24 months, between preconception, pregnancy and 2 months postpartum
Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes
Measured by questionnaires, accelerometer, digital sensor and/or biomarkers
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Acceptability and adherence levels
From questionnaire, with higher score indicates higher acceptability and adherence
Time frame: Up to 40 months, at preconception, pregnancy and 18 months postpartum
Satisfactory level of participants with the HELMS program
From patient satisfaction questionnaire in a Likert scale, with a higher score suggesting greater satisfaction
Time frame: Up to 40 months, at preconception, pregnancy and 18 months postpartum