Healthy Early Life Moments in Singapore

Not Applicable

Recruiting

• Conditions: Metabolic Disease; Mental Health Wellness 1; Maternal Obesity; Lifestyle Risk Reduction
• Interventions: Behavioral: HELMS Lifestyle Intervention

• Registration Number: NCT05207059
• Lead Sponsor: KK Women's and Children's Hospital

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.

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-26
• Study Start: 2022-03-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	HELMS Lifestyle Intervention	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.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	Up to 12 months	Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages
Maternal metabolic health	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Evaluated by metabolic syndrome criteria
Maternal mental health	Up to 26 months, between preconception, pregnancy and 4 months postpartum	Measured by Edinburgh Postnatal Depression Scale, scored between 0 to 30, with a higher score being suggestive of depression

Secondary Outcome Measures

Name	Time	Method
Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by questionnaires, accelerometer, digital sensor and/or biomarkers
Acceptability and adherence levels	Up to 40 months, at preconception, pregnancy and 18 months postpartum	From questionnaire, with higher score indicates higher acceptability and adherence
Satisfactory level of participants with the HELMS program	Up to 40 months, at preconception, pregnancy and 18 months postpartum	From patient satisfaction questionnaire in a Likert scale, with a higher score suggesting greater satisfaction
Maternal dietary behaviour - TFEQ	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by Three Factor Eating Questionnaire, based on the scores from each category
Maternal micronutrient status	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Micronutrient panel from plasma or breastmilk such as 1-carbon metabolites, vitamin D and E, expressed in SI units of respective micronutrients
Maternal physical activity level - self assessment	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by International Physical Activity Questionnaire, with a higher score suggesting higher physical activity level
Maternal physical activity	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by accelerometer and/or digital sensor, in respective SI units
Maternal sedentary behaviour - self assessment	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by sedentary behaviour questionnaire, in hours and minutes per day, with longer duration suggestive of greater sedentary behaviour
Maternal sedentary behaviour	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by accelerometer and/or digital sensor, in respective SI units
Maternal sleep - PSQI	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by Pittsburgh Sleep Quality Index, scored from 0-21, with higher score suggestive of poor sleep quality
Maternal sleep	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by accelerometer and/or digital sensor, in respective SI units
Maternal emotional wellbeing	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by questionnaires
Maternal ocular health	Up to 21 months, from preconception until 36 weeks gestation	Measured by retinal and choroidal characteristics using three-dimensional volumetric (OCT-A) imaging systems
Maternal personality trait	At preconception	Measured by M5-50 questionnaire, with classification into respective personality types
Duration of gestation	Up to 42 weeks, between estimated date of conception from menstrual and ultrasound scan and date of delivery	Defined as the length of pregnancy, in months and days
Number of participants with gestational diabetes	Up to 20 weeks, between 12 and 32 weeks gestation	Determined by oral glucose tolerance test during pregnancy
Number of participants with hypertensive disorders of pregnancy	Up to 42 weeks, between date of conception and date of delivery	Including pregnancy-induced hypertension and pre-eclampsia/eclampsia from questionnaire and/or retrieved from medical records
Mode of labour onset, course of delivery and delivery outcomes	Delivery	From questionnaire and/or retrieved from medical records, reported in percentages
Maternal pain	Up to 5 months, between 32 weeks gestation and 6-8 weeks post-delivery	Measured by pain questionnaire
Antenatal, perinatal and postnatal complications	Up to 50 weeks, between date of conception and up to 8 weeks postpartum	From questionnaire and/or retrieved from medical records, reported in percentages
Neonatal complications and admission to neonatal care facilities	Up to 4 weeks, between date of delivery and 4 weeks post-delivery	From questionnaire and/or retrieved from medical records, reported in percentages
Offspring body weight	Up to 18 months, from birth to infant age 18 months	Weight measured in grams
Offspring body size at birth	At birth	Adjusted for gestational age and sex, expressed in percentile
Offspring body length	Up to 18 months, from birth to infant age 18 months	Measured in centimeters
Offspring head circumference	Up to 18 months, from birth to infant age 18 months	Measured in centimeters
Intrauterine growth of foetus	Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation	As assessed by antenatal serial ultrasound scans to determine head and abdominal circumference, femur length and estimated foetal weight
Offspring feeding	Up to 18 months, from birth to infant age 18 months	Measured types of feeding using questionnaires
Offspring gut microbiome	Up to 18 months, from birth to infant age 18 months	Measured from stool samples
Maternal gut microbiome	Up to 24 months, between preconception, pregnancy and 2 months postpartum	Measured from stool samples
Maternal abdominal fat	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Determined from waist hip circumferences in ratio
Maternal dietary pattern	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by food diary and/or food frequency questionnaire using factor loading analysis
Maternal food timing	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by food diary in time phase
Maternal eating episodes	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by food diary in eating frequency
Maternal dietary behaviour - 6P	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by 6P Questionnaire based on each factor in the questionnaire
Fecundability	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 time to pregnancy in total discrete cycles at risk of pregnancy
Female sexual function	Up to 3 months, between date of recruitment and 3 months preconception follow-up	Measured by Female Sexual Function Index, with a higher score being suggestive of better sexual function
Pregnancy loss rate	Up to 42 weeks, between date of conception and date of delivery	Based on ultrasound scan and medical records, in percentage
Live birth rates	Up to 42 weeks, between date of conception and date of delivery	Based on ultrasound scan and medical records, in percentage
Maternal lipid levels	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Including total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, in mmol/L
Maternal glycaemic marker - plasma glucose	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by plasma glucose levels, in mmol/L
Maternal glycaemic marker - HbA1c	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by HbA1c, in percentage
Maternal glycaemic marker - C-peptide	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by C-peptide, in SI unit
Maternal glycaemic markers - Insulin	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by serum insulin, in SI unit
Maternal glucose tolerance status	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by Oral Glucose Tolerance Test (OGTT), in mmol/L
Maternal blood pressure	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by blood pressure device for systolic and diastolic pressures in mmHg
Maternal heart rate	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by blood pressure device or sensor in beats per minutes
Maternal body weight	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by weighing scale in kilograms
Maternal body weight status	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Determined by body mass index based on weight (kg) /height (m)2
Maternal body fat distribution	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Determined from waist hip circumferences in centimeters
Maternal body composition	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Determined from body fat analysis in percentages
Maternal body fat mass	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Determined from body fat analysis in percentages
Maternal visceral fat	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Determined from body fat analysis in volumes
Maternal body lean mass	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Determined from body fat analysis in percentages
Maternal nutrient intake	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by food diary and/or food frequency questionnaire in SI units of respective nutrients
Maternal food intake	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by food diary and/or food frequency questionnaire in serving sizes
Maternal food intakes	Up to 40 months, between preconception, pregnancy and 18 months postpartum	Measured by food diary and/or food frequency questionnaire in grams

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore