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| Name | Class |
|---|---|
| Lien Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HELMS Lifestyle Intervention | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Wen Ng, MPH | Contact | +65 6394 8113 | ng.xiang.wen@kkh.com.sg | |
| Lan Tian Lai, MSc | Contact | lai.lan.tian@kkh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Jerry Chan, MB BCh BaO MA FRCOG PhD | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Recruiting | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42331590 | Derived | 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. | |
| 36523242 |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D040242 | Risk Reduction Behavior |
| D000079262 | Pregnancy in Obesity |
| D009765 | Obesity |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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|
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 |
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 |
| Chan 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. |
| D000091642 | Urogenital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |