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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health Wellness 1; Metabolic Disease; Maternal Obesity; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: HELMS Lifestyle Intervention

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Wen Ng, MPH; Phone Number: +65 6394 8113; Email: ng.xiang.wen@kkh.com.sg
• Study Contact Backup: Name: Lan Tian Lai, MSc; Email: lai.lan.tian@kkh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • Recruiting
    • KK Women's and Children's Hospital
    • Contact: Lan Tian Lai, MSc; Email: lai.lan.tian@kkh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Arm; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health economics analysis of the HELMS program	Cost benefit analysis from health expenses and diseases outcomes	Composite analysis between preconception visit which is up to 12 months before pregnancy and until infant age 18 months
Maternal general health and wellbeing	From questionnaire, expressed in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Offspring health and general wellbeing	From questionnaire and/or medical records, expressed in percentages	Up to 18 months, from birth to infant age 18 months
Offspring metabolomic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Offspring genomic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Offspring epigenetic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Offspring biochemical profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Offspring metabolic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Offspring immunological profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Offspring molecular profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Maternal metabolomic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal genomic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal epigenetic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal temperature	Measured by skin temperature sensor, in degree celsius	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal biochemical profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal metabolic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal immunological profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal molecular profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body weight	Measured by weighing scale, in kilograms	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal 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
Paternal body fat distribution	Determined from waist hip circumferences in centimetres	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal abdominal fat	Determined from waist hip circumferences in ratio	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body composition	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body fat mass	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body lean mass	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body visceral fat	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal health and general well-being - self assessment	From questionnaires	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal health and general well-being	From digital sensor	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal immunological profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal biochemical profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal metabolic profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal molecular profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Breast milk macronutrient profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Breast milk micronutrient profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Breast milk immune factor profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Breast milk epigenetic profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Breast milk biochemical profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Breast milk metabolic profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Breast milk microbiome profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Breast milk molecular profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Maternal transcriptomics	From blood and/or breast milk samples	Up to 36 months, between preconception, pregnancy and 1 year postpartum
Infant transcriptomics	From blood	Up to 36 months, between preconception, pregnancy and 1 year postpartum

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: Lien Foundation
• Investigators: Principal Investigator: Jerry Chan, MB BCh BaO MA FRCOG PhD, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Mental health; Lifestyle intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Obesity; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Metabolic Diseases; Obesity, Maternal
• Other Study ID Numbers: 2021/2247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No