Healthy Early Life Moments in Singapore

Study Overview
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Brief Summary
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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
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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.

Official Title
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Healthy Early Life Moments in Singapore

Conditions
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Metabolic Disease, Mental Health Wellness 1, Lifestyle Risk Reduction, Maternal Obesity

Intervention / Treatment
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* Behavioral: HELMS Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>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. | Behavioral: HELMS Lifestyle Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages | Up to 12 months | 
| Maternal metabolic health | Evaluated by metabolic syndrome criteria | 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 | Up to 26 months, between preconception, pregnancy and 4 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecundability | Measured by time to pregnancy in total discrete cycles at risk of pregnancy | 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 | 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 | Up to 42 weeks, between date of conception and date of delivery | 
| Live birth rates | Based on ultrasound scan and medical records, in percentage | Up to 42 weeks, between date of conception and date of delivery | 
| Maternal lipid levels | Including total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, in mmol/L | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal glycaemic marker - plasma glucose | Measured by plasma glucose levels, in mmol/L | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal glycaemic marker - HbA1c | Measured by HbA1c, in percentage | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal glycaemic marker - C-peptide | Measured by C-peptide, in SI unit | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal glycaemic markers - Insulin | Measured by serum insulin, in SI unit | 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 | 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 | 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 | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal body weight | Measured by weighing scale in kilograms | 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 | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal body fat distribution | Determined from waist hip circumferences in centimeters | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal abdominal fat | Determined from waist hip circumferences in ratio | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal body composition | Determined from body fat analysis in percentages | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal body fat mass | Determined from body fat analysis in percentages | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal visceral fat | Determined from body fat analysis in volumes | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal body lean mass | Determined from body fat analysis in percentages | 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 | 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 | 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 | 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 | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal food timing | Measured by food diary in time phase | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal eating episodes | Measured by food diary in eating frequency | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal sleep | Measured by accelerometer and/or digital sensor, in respective SI units | Up to 40 months, between preconception, pregnancy and 18 months postpartum | 
| Maternal emotional wellbeing | Measured by questionnaires | 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) | 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 | Up to 21 months, from preconception until 36 weeks gestation | 
| Maternal personality trait | Measured by M5-50 questionnaire, with classification into respective personality types | At preconception | 
| Duration of gestation | Defined as the length of pregnancy, in months and days | 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 | 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 | 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 | Delivery | 
| Maternal pain | Measured by pain questionnaire | 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 | 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 | Up to 4 weeks, between date of delivery and 4 weeks post-delivery | 
| Offspring body weight | Weight measured in grams | 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 | At birth | 
| Offspring body length | Measured in centimeters | Up to 18 months, from birth to infant age 18 months | 
| Offspring head circumference | Measured in centimeters | 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 | Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation | 
| Offspring feeding | Measured types of feeding using questionnaires | Up to 18 months, from birth to infant age 18 months | 
| Offspring gut microbiome | Measured from stool samples | Up to 18 months, from birth to infant age 18 months | 
| Maternal gut microbiome | Measured from stool samples | 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 | 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 | 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 | Up to 40 months, at preconception, pregnancy and 18 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Mental health, Lifestyle intervention