An interventional study of HELMS Lifestyle Intervention in Metabolic Disease, Mental Health Wellness 1 and Lifestyle Risk Reduction, sponsored by KK Women's and Children's Hospital. Active, not recruiting at 1 site in Singapore. Open to female participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Prevention
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.
763 studies on the registry are indexed under Metabolic Diseases; 192 are open to participants now.
This study's planned enrollment of 500 is above the median of 50 across 525 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →KK Women's and Children's Hospital is the lead sponsor of 137 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Pregnancy rate
Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages
Time frame: Up to 12 months
Maternal metabolic health
Evaluated by metabolic syndrome criteria
Time frame: 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
Time frame: Up to 26 months, between preconception, pregnancy and 4 months postpartum
Fecundability
Measured by time to pregnancy in total discrete cycles at risk of pregnancy
Time frame: 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
Time frame: 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
Time frame: Up to 42 weeks, between date of conception and date of delivery
Live birth rates
Based on ultrasound scan and medical records, in percentage
Time frame: 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
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - plasma glucose
Measured by plasma glucose levels, in mmol/L
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - HbA1c
Measured by HbA1c, in percentage
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - C-peptide
Measured by C-peptide, in SI unit
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic markers - Insulin
Measured by serum insulin, in SI unit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body weight
Measured by weighing scale in kilograms
Time frame: 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
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body fat distribution
Determined from waist hip circumferences in centimeters
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal abdominal fat
Determined from waist hip circumferences in ratio
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body composition
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body fat mass
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal visceral fat
Determined from body fat analysis in volumes
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body lean mass
Determined from body fat analysis in percentages
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal food timing
Measured by food diary in time phase
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal eating episodes
Measured by food diary in eating frequency
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal sleep
Measured by accelerometer and/or digital sensor, in respective SI units
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal emotional wellbeing
Measured by questionnaires
Time frame: 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)
Time frame: 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
Time frame: Up to 21 months, from preconception until 36 weeks gestation
Maternal personality trait
Measured by M5-50 questionnaire, with classification into respective personality types
Time frame: At preconception
Duration of gestation
Defined as the length of pregnancy, in months and days
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Delivery
Maternal pain
Measured by pain questionnaire
Time frame: 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
Time frame: 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
Time frame: Up to 4 weeks, between date of delivery and 4 weeks post-delivery
Offspring body weight
Weight measured in grams
Time frame: 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
Time frame: At birth
Offspring body length
Measured in centimeters
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring head circumference
Measured in centimeters
Time frame: 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
Time frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Offspring feeding
Measured types of feeding using questionnaires
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring gut microbiome
Measured from stool samples
Time frame: Up to 18 months, from birth to infant age 18 months
Maternal gut microbiome
Measured from stool samples
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 40 months, at preconception, pregnancy and 18 months postpartum
Health economics analysis of the HELMS program
Cost benefit analysis from health expenses and diseases outcomes
Time frame: 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
Time frame: 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
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring metabolomic profile
From cord blood, placenta, infant blood and/or skin biopsy
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring genomic profile
From cord blood, placenta, infant blood and/or skin biopsy
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring epigenetic profile
From cord blood, placenta, infant blood and/or skin biopsy
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring biochemical profile
From cord blood, placenta, infant blood and/or skin biopsy
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring metabolic profile
From cord blood, placenta, infant blood and/or skin biopsy
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring immunological profile
From cord blood, placenta, infant blood and/or skin biopsy
Time frame: Up to 18 months, from birth to infant age 18 months
Offspring molecular profile
From cord blood, placenta, infant blood and/or skin biopsy
Time frame: Up to 18 months, from birth to infant age 18 months
Maternal metabolomic profile
From blood, urine and/or saliva samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal genomic profile
From blood, urine and/or saliva samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal epigenetic profile
From blood, urine and/or saliva samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal temperature
Measured by skin temperature sensor, in degree celsius
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal biochemical profile
From blood, urine and/or saliva samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal metabolic profile
From blood, urine and/or saliva samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal immunological profile
From blood, urine and/or saliva samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal molecular profile
From blood, urine and/or saliva samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body weight
Measured by weighing scale, in kilograms
Time frame: 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
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body fat distribution
Determined from waist hip circumferences in centimetres
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal abdominal fat
Determined from waist hip circumferences in ratio
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body composition
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body fat mass
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body lean mass
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal body visceral fat
Determined from body fat analysis in percentages
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal health and general well-being - self assessment
From questionnaires
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal health and general well-being
From digital sensor
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal immunological profile
From blood and/or urine samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal biochemical profile
From blood and/or urine samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal metabolic profile
From blood and/or urine samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Paternal molecular profile
From blood and/or urine samples
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Breast milk macronutrient profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk micronutrient profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk immune factor profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk epigenetic profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk biochemical profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk metabolic profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk microbiome profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk molecular profile (subsample)
From breast milk sample
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Maternal transcriptomics
From blood and/or breast milk samples
Time frame: Up to 36 months, between preconception, pregnancy and 1 year postpartum
Infant transcriptomics
From blood
Time frame: Up to 36 months, between preconception, pregnancy and 1 year postpartum
Plan to share: No
Started Mar 2022 (actual). Primary completion is estimated for Dec 2027, 69 months after the start.
Of 182 non-industry interventional studies with no phase under Metabolic Diseases, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's planned 69 months is above that.
Counting every sponsor, half of 201 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
KK Women's and Children's Hospital →