Healthy Early Life Moments in Singapore (HELMS)

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.

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.

The intervention will comprise four modules, namely the HELMS Journey, HELMS Model, HELMS Lifestyle and HELMS Community. The HELMS Journey will provide anticipatory guidance for both HELMS and routine clinic visits. The HELMS Model will deliver the 4S ('Screening', 'Size', 'Supplementation' and 'Specific case management') care plan, detailed below. The HELMS Lifestyle will provide lifestyle support in terms of healthy eating through the 6P tool ('Portion', 'Proportion', 'Pleasure', 'Phase', Physicality', 'Psychology'), physical activity, sleep and mental well-being. Finally, the HELMS Connection will provide community support and improve engagement with the program.

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.

Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages

Measured by Edinburgh Postnatal Depression Scale, scored between 0 to 30, with a higher score being suggestive of depression

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)

Measured by Female Sexual Function Index, with a higher score being suggestive of better sexual function

Micronutrient panel from plasma or breastmilk such as 1-carbon metabolites, vitamin D and E, expressed in SI units of respective micronutrients

Measured by International Physical Activity Questionnaire, with a higher score suggesting higher physical activity level

Measured by sedentary behaviour questionnaire, in hours and minutes per day, with longer duration suggestive of greater sedentary behaviour

Measured by Pittsburgh Sleep Quality Index, scored from 0-21, with higher score suggestive of poor sleep quality

Measured by retinal vessel characteristics (including vessel caliber, geometric assessment and vasoreactivity)

Measured by retinal and choroidal characteristics using three-dimensional volumetric (OCT-A) imaging systems

Up to 42 weeks, between estimated date of conception from menstrual and ultrasound scan and date of delivery

Including pregnancy-induced hypertension and pre-eclampsia/eclampsia from questionnaire and/or retrieved from medical records

As assessed by antenatal serial ultrasound scans to determine head and abdominal circumference, femur length and estimated foetal weight

Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes

From patient satisfaction questionnaire in a Likert scale, with a higher score suggesting greater satisfaction

Composite analysis between preconception visit which is up to 12 months before pregnancy and until infant age 18 months

Inclusion Criteria: Women aged 21-40 years BMI 25-40 kg/m2 Intention to reside in Singapore for the next 4 years Chinese, Malay, Indian or any combination of these 3 ethnic groups Planning to conceive within 1 year Able to understand English Able to provide written, informed consent Exclusion Criteria: Currently pregnant Known type 1 or type 2 diabetes On any anticonvulsant medication in the past 1 month On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron) On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene/ Letrozole in the past 1 month On HIV or Hepatitis B or C medication in the past 1 month.