Metabolic DiseaseHELMSNCT05207059
Healthy Early Life Moments in Singapore
A study testing HELMS Lifestyle Intervention in people with Metabolic Disease and Mental Health Wellness 1, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Mental Health Wellness 1, Lifestyle Risk Reduction
- What is being tested?
- HELMS Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Mar 2022to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- HELMS Lifestyle Intervention
- Keywords
- Obesity, Mental health, Lifestyle intervention
- Medical subject headings
- Metabolic Diseases, Risk Reduction Behavior, Pregnancy in Obesity, Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELMS Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | 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. Receives: Behavioral: HELMS Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages
Measured: Up to 12 months
Maternal metabolic health
Evaluated by metabolic syndrome criteria
Measured: 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
Measured: Up to 26 months, between preconception, pregnancy and 4 months postpartum
Secondary outcomes (57)
Fecundability
Measured by time to pregnancy in total discrete cycles at risk of pregnancy
Measured: 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
Measured: 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
Measured: Up to 42 weeks, between date of conception and date of delivery
Live birth rates
Based on ultrasound scan and medical records, in percentage
Measured: 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
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - plasma glucose
Measured by plasma glucose levels, in mmol/L
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - HbA1c
Measured by HbA1c, in percentage
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic marker - C-peptide
Measured by C-peptide, in SI unit
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal glycaemic markers - Insulin
Measured by serum insulin, in SI unit
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body weight
Measured by weighing scale in kilograms
Measured: 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
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body fat distribution
Determined from waist hip circumferences in centimeters
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal abdominal fat
Determined from waist hip circumferences in ratio
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body composition
Determined from body fat analysis in percentages
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body fat mass
Determined from body fat analysis in percentages
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal visceral fat
Determined from body fat analysis in volumes
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal body lean mass
Determined from body fat analysis in percentages
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal food timing
Measured by food diary in time phase
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal eating episodes
Measured by food diary in eating frequency
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal sleep
Measured by accelerometer and/or digital sensor, in respective SI units
Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal emotional wellbeing
Measured by questionnaires
Measured: 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)
Measured: 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
Measured: Up to 21 months, from preconception until 36 weeks gestation
Maternal personality trait
Measured by M5-50 questionnaire, with classification into respective personality types
Measured: At preconception
Duration of gestation
Defined as the length of pregnancy, in months and days
Measured: 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
Measured: 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
Measured: 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
Measured: Delivery
Maternal pain
Measured by pain questionnaire
Measured: 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
Measured: 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
Measured: Up to 4 weeks, between date of delivery and 4 weeks post-delivery
Offspring body weight
Weight measured in grams
Measured: 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
Measured: At birth
Offspring body length
Measured in centimeters
Measured: Up to 18 months, from birth to infant age 18 months
Offspring head circumference
Measured in centimeters
Measured: 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
Measured: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Offspring feeding
Measured types of feeding using questionnaires
Measured: Up to 18 months, from birth to infant age 18 months
Offspring gut microbiome
Measured from stool samples
Measured: Up to 18 months, from birth to infant age 18 months
Maternal gut microbiome
Measured from stool samples
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 40 months, at preconception, pregnancy and 18 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start18 Mar 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Lien Foundation
- Responsible party
- Sponsor
- Investigators
- Jerry Chan, MB BCh BaO MA FRCOG PhD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207059
- Sponsor's protocol ID
- 2021/2247
- Acronym
- HELMS
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2021
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zay Ya K, Ku CW, Loy SL, Ngien A, Mok KT, Chua MC, Yap F, Chan JKY, Martin E. Economic evaluation of the Healthy Early Life Moments in Singapore (HELMS) programme: a study protocol for an integrated lifestyle intervention supported by a mobile health tool for mothers and children in Singapore. BMJ Open. 2026 Jun 22;16(6):e116421. doi: 10.1136/bmjopen-2026-116421.
PubMed 42331590Chan JKY, Ku CW, Loy SL, Godfrey KM, Fan Y, Chua MC, Yap F. Effects of an integrated mobile health lifestyle intervention among overweight and obese women planning for pregnancy in Singapore: protocol for the single-arm healthy early life moments in Singapore (HELMS) study. BMJ Open. 2022 Dec 12;12(12):e061556. doi: 10.1136/bmjopen-2022-061556.
PubMed 36523242