Healthy Early Life Moments in Singapore

Metabolic Disease Clinical Trial

— HELMS  

Official title:

Healthy Early Life Moments in Singapore

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207059
• Other study ID #: 2021/2247
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: December 2028

Study information

• Verified date: October 2023
• Source: KK Women's and Children's Hospital
• Contact: Xiang Wen Ng, MPH
• Phone: +65 6394 8113
• Email: ng.xiang.wen[@]kkh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lifestyle Risk Reduction
• Maternal Obesity
• Mental Health Wellness 1
• Metabolic Disease
• Metabolic Diseases

Intervention

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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Lien Foundation

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Maternal general health and wellbeing	From questionnaire, expressed in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	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
Other	Offspring metabolomic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Other	Offspring genomic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Other	Offspring epigenetic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Other	Offspring biochemical profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Other	Offspring metabolic profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Other	Offspring immunological profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Other	Offspring molecular profile	From cord blood, placenta, infant blood and/or skin biopsy	Up to 18 months, from birth to infant age 18 months
Other	Maternal metabolomic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Maternal genomic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Maternal epigenetic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Maternal temperature	Measured by skin temperature sensor, in degree celsius	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Maternal biochemical profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Maternal metabolic profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Maternal immunological profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Maternal molecular profile	From blood, urine and/or saliva samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal body weight	Measured by weighing scale, in kilograms	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	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
Other	Paternal body fat distribution	Determined from waist hip circumferences in centimetres	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal abdominal fat	Determined from waist hip circumferences in ratio	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal body composition	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal body fat mass	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal body lean mass	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal body visceral fat	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal health and general well-being - self assessment	From questionnaires	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal health and general well-being	From digital sensor	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal immunological profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal biochemical profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal metabolic profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Paternal molecular profile	From blood and/or urine samples	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Other	Breast milk macronutrient profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Breast milk micronutrient profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Breast milk immune factor profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Breast milk epigenetic profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Breast milk biochemical profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Breast milk metabolic profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Breast milk microbiome profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Breast milk molecular profile (subsample)	From breast milk sample	Up to 1 year, between date of delivery and 1 year postpartum
Other	Maternal transcriptomics	From blood and/or breast milk samples	Up to 36 months, between preconception, pregnancy and 1 year postpartum
Other	Infant transcriptomics	From blood	Up to 36 months, between preconception, pregnancy and 1 year postpartum
Primary	Pregnancy rate	Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages	Up to 12 months
Primary	Maternal metabolic health	Evaluated by metabolic syndrome criteria	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Primary	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	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)
Secondary	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
Secondary	Pregnancy loss rate	Based on ultrasound scan and medical records, in percentage	Up to 42 weeks, between date of conception and date of delivery
Secondary	Live birth rates	Based on ultrasound scan and medical records, in percentage	Up to 42 weeks, between date of conception and date of delivery
Secondary	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
Secondary	Maternal glycaemic marker - plasma glucose	Measured by plasma glucose levels, in mmol/L	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal glycaemic marker - HbA1c	Measured by HbA1c, in percentage	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal glycaemic marker - C-peptide	Measured by C-peptide, in SI unit	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal glycaemic markers - Insulin	Measured by serum insulin, in SI unit	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal body weight	Measured by weighing scale in kilograms	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	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
Secondary	Maternal body fat distribution	Determined from waist hip circumferences in centimeters	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal abdominal fat	Determined from waist hip circumferences in ratio	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal body composition	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal body fat mass	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal visceral fat	Determined from body fat analysis in volumes	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal body lean mass	Determined from body fat analysis in percentages	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal food timing	Measured by food diary in time phase	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal eating episodes	Measured by food diary in eating frequency	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal sleep	Measured by accelerometer and/or digital sensor, in respective SI units	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal emotional wellbeing	Measured by questionnaires	Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	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
Secondary	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
Secondary	Maternal personality trait	Measured by M5-50 questionnaire, with classification into respective personality types	At preconception
Secondary	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
Secondary	Number of participants with gestational diabetes	Determined by oral glucose tolerance test during pregnancy	Up to 20 weeks, between 12 and 32 weeks gestation
Secondary	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
Secondary	Mode of labour onset, course of delivery and delivery outcomes	From questionnaire and/or retrieved from medical records, reported in percentages	Delivery
Secondary	Maternal pain	Measured by pain questionnaire	Up to 5 months, between 32 weeks gestation and 6-8 weeks post-delivery
Secondary	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
Secondary	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
Secondary	Offspring body weight	Weight measured in grams	Up to 18 months, from birth to infant age 18 months
Secondary	Offspring body size at birth	Adjusted for gestational age and sex, expressed in percentile	At birth
Secondary	Offspring body length	Measured in centimeters	Up to 18 months, from birth to infant age 18 months
Secondary	Offspring head circumference	Measured in centimeters	Up to 18 months, from birth to infant age 18 months
Secondary	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
Secondary	Offspring feeding	Measured types of feeding using questionnaires	Up to 18 months, from birth to infant age 18 months
Secondary	Offspring gut microbiome	Measured from stool samples	Up to 18 months, from birth to infant age 18 months
Secondary	Maternal gut microbiome	Measured from stool samples	Up to 24 months, between preconception, pregnancy and 2 months postpartum
Secondary	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
Secondary	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
Secondary	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