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NCT Number: NCT05207059

Healthy Early Life Moments in Singapore

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.

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Key information

Conditions

Metabolic Disease Behavior Body Weight Female Urogenital Diseases and Pregnancy Complications Lifestyle Risk Reduction Maternal Obesity Mental Health Wellness 1 Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Pregnancy Complications Pregnancy in Obesity Psychological Well-Being Risk Reduction Behavior Signs and Symptoms Urogenital Diseases

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

Location status: Recruiting

Location contact

Lan Tian Lai, MSc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Pregnancy rate

    Time frame: Up to 12 months

    Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages

  2. Maternal metabolic health

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Evaluated by metabolic syndrome criteria

  3. Maternal mental health

    Time frame: Up to 26 months, between preconception, pregnancy and 4 months postpartum

    Measured by Edinburgh Postnatal Depression Scale, scored between 0 to 30, with a higher score being suggestive of depression

Secondary outcomes

  1. Fecundability

    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)

    Measured by time to pregnancy in total discrete cycles at risk of pregnancy

  2. Female sexual function

    Time frame: Up to 3 months, between date of recruitment and 3 months preconception follow-up

    Measured by Female Sexual Function Index, with a higher score being suggestive of better sexual function

  3. Pregnancy loss rate

    Time frame: Up to 42 weeks, between date of conception and date of delivery

    Based on ultrasound scan and medical records, in percentage

  4. Live birth rates

    Time frame: Up to 42 weeks, between date of conception and date of delivery

    Based on ultrasound scan and medical records, in percentage

  5. Maternal lipid levels

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Including total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, in mmol/L

  6. Maternal glycaemic marker - plasma glucose

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by plasma glucose levels, in mmol/L

  7. Maternal glycaemic marker - HbA1c

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by HbA1c, in percentage

  8. Maternal glycaemic marker - C-peptide

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by C-peptide, in SI unit

  9. Maternal glycaemic markers - Insulin

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by serum insulin, in SI unit

  10. Maternal glucose tolerance status

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by Oral Glucose Tolerance Test (OGTT), in mmol/L

  11. Maternal blood pressure

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by blood pressure device for systolic and diastolic pressures in mmHg

  12. Maternal heart rate

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by blood pressure device or sensor in beats per minutes

  13. Maternal body weight

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by weighing scale in kilograms

  14. Maternal body weight status

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined by body mass index based on weight (kg) /height (m)2

  15. Maternal body fat distribution

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from waist hip circumferences in centimeters

  16. Maternal abdominal fat

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from waist hip circumferences in ratio

  17. Maternal body composition

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in percentages

  18. Maternal body fat mass

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in percentages

  19. Maternal visceral fat

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in volumes

  20. Maternal body lean mass

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in percentages

  21. Maternal nutrient intake

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by food diary and/or food frequency questionnaire in SI units of respective nutrients

  22. Maternal food intake

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by food diary and/or food frequency questionnaire in serving sizes

  23. Maternal food intakes

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by food diary and/or food frequency questionnaire in grams

  24. Maternal dietary pattern

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by food diary and/or food frequency questionnaire using factor loading analysis

  25. Maternal food timing

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by food diary in time phase

  26. Maternal eating episodes

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by food diary in eating frequency

  27. Maternal dietary behaviour - 6P

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by 6P Questionnaire based on each factor in the questionnaire

  28. Maternal dietary behaviour - TFEQ

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by Three Factor Eating Questionnaire, based on the scores from each category

  29. Maternal micronutrient status

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Micronutrient panel from plasma or breastmilk such as 1-carbon metabolites, vitamin D and E, expressed in SI units of respective micronutrients

  30. Maternal physical activity level - self assessment

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by International Physical Activity Questionnaire, with a higher score suggesting higher physical activity level

  31. Maternal physical activity

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by accelerometer and/or digital sensor, in respective SI units

  32. Maternal sedentary behaviour - self assessment

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by sedentary behaviour questionnaire, in hours and minutes per day, with longer duration suggestive of greater sedentary behaviour

  33. Maternal sedentary behaviour

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by accelerometer and/or digital sensor, in respective SI units

  34. Maternal sleep - PSQI

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by Pittsburgh Sleep Quality Index, scored from 0-21, with higher score suggestive of poor sleep quality

  35. Maternal sleep

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by accelerometer and/or digital sensor, in respective SI units

  36. Maternal emotional wellbeing

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by questionnaires

  37. Maternal ocular health

    Time frame: Up to 21 months, from preconception until 36 weeks gestation

    Measured by retinal vessel characteristics (including vessel caliber, geometric assessment and vasoreactivity)

  38. Maternal ocular health

    Time frame: Up to 21 months, from preconception until 36 weeks gestation

    Measured by retinal and choroidal characteristics using three-dimensional volumetric (OCT-A) imaging systems

  39. Maternal personality trait

    Time frame: At preconception

    Measured by M5-50 questionnaire, with classification into respective personality types

  40. Duration of gestation

    Time frame: Up to 42 weeks, between estimated date of conception from menstrual and ultrasound scan and date of delivery

    Defined as the length of pregnancy, in months and days

  41. Number of participants with gestational diabetes

    Time frame: Up to 20 weeks, between 12 and 32 weeks gestation

    Determined by oral glucose tolerance test during pregnancy

  42. Number of participants with hypertensive disorders of pregnancy

    Time frame: Up to 42 weeks, between date of conception and date of delivery

    Including pregnancy-induced hypertension and pre-eclampsia/eclampsia from questionnaire and/or retrieved from medical records

  43. Mode of labour onset, course of delivery and delivery outcomes

    Time frame: Delivery

    From questionnaire and/or retrieved from medical records, reported in percentages

  44. Maternal pain

    Time frame: Up to 5 months, between 32 weeks gestation and 6-8 weeks post-delivery

    Measured by pain questionnaire

  45. Antenatal, perinatal and postnatal complications

    Time frame: Up to 50 weeks, between date of conception and up to 8 weeks postpartum

    From questionnaire and/or retrieved from medical records, reported in percentages

  46. Neonatal complications and admission to neonatal care facilities

    Time frame: Up to 4 weeks, between date of delivery and 4 weeks post-delivery

    From questionnaire and/or retrieved from medical records, reported in percentages

  47. Offspring body weight

    Time frame: Up to 18 months, from birth to infant age 18 months

    Weight measured in grams

  48. Offspring body size at birth

    Time frame: At birth

    Adjusted for gestational age and sex, expressed in percentile

  49. Offspring body length

    Time frame: Up to 18 months, from birth to infant age 18 months

    Measured in centimeters

  50. Offspring head circumference

    Time frame: Up to 18 months, from birth to infant age 18 months

    Measured in centimeters

  51. Intrauterine growth of foetus

    Time frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation

    As assessed by antenatal serial ultrasound scans to determine head and abdominal circumference, femur length and estimated foetal weight

  52. Offspring feeding

    Time frame: Up to 18 months, from birth to infant age 18 months

    Measured types of feeding using questionnaires

  53. Offspring gut microbiome

    Time frame: Up to 18 months, from birth to infant age 18 months

    Measured from stool samples

  54. Maternal gut microbiome

    Time frame: Up to 24 months, between preconception, pregnancy and 2 months postpartum

    Measured from stool samples

  55. Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by questionnaires, accelerometer, digital sensor and/or biomarkers

  56. Acceptability and adherence levels

    Time frame: Up to 40 months, at preconception, pregnancy and 18 months postpartum

    From questionnaire, with higher score indicates higher acceptability and adherence

  57. Satisfactory level of participants with the HELMS program

    Time frame: Up to 40 months, at preconception, pregnancy and 18 months postpartum

    From patient satisfaction questionnaire in a Likert scale, with a higher score suggesting greater satisfaction

Other outcomes

  1. Health economics analysis of the HELMS program

    Time frame: Composite analysis between preconception visit which is up to 12 months before pregnancy and until infant age 18 months

    Cost benefit analysis from health expenses and diseases outcomes

  2. Maternal general health and wellbeing

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From questionnaire, expressed in percentages

  3. Offspring health and general wellbeing

    Time frame: Up to 18 months, from birth to infant age 18 months

    From questionnaire and/or medical records, expressed in percentages

  4. Offspring metabolomic profile

    Time frame: Up to 18 months, from birth to infant age 18 months

    From cord blood, placenta, infant blood and/or skin biopsy

  5. Offspring genomic profile

    Time frame: Up to 18 months, from birth to infant age 18 months

    From cord blood, placenta, infant blood and/or skin biopsy

  6. Offspring epigenetic profile

    Time frame: Up to 18 months, from birth to infant age 18 months

    From cord blood, placenta, infant blood and/or skin biopsy

  7. Offspring biochemical profile

    Time frame: Up to 18 months, from birth to infant age 18 months

    From cord blood, placenta, infant blood and/or skin biopsy

  8. Offspring metabolic profile

    Time frame: Up to 18 months, from birth to infant age 18 months

    From cord blood, placenta, infant blood and/or skin biopsy

  9. Offspring immunological profile

    Time frame: Up to 18 months, from birth to infant age 18 months

    From cord blood, placenta, infant blood and/or skin biopsy

  10. Offspring molecular profile

    Time frame: Up to 18 months, from birth to infant age 18 months

    From cord blood, placenta, infant blood and/or skin biopsy

  11. Maternal metabolomic profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood, urine and/or saliva samples

  12. Maternal genomic profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood, urine and/or saliva samples

  13. Maternal epigenetic profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood, urine and/or saliva samples

  14. Maternal temperature

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by skin temperature sensor, in degree celsius

  15. Maternal biochemical profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood, urine and/or saliva samples

  16. Maternal metabolic profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood, urine and/or saliva samples

  17. Maternal immunological profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood, urine and/or saliva samples

  18. Maternal molecular profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood, urine and/or saliva samples

  19. Paternal body weight

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Measured by weighing scale, in kilograms

  20. Paternal body weight status

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined by body mass index based on weight (kg) /height (m)2

  21. Paternal body fat distribution

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from waist hip circumferences in centimetres

  22. Paternal abdominal fat

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from waist hip circumferences in ratio

  23. Paternal body composition

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in percentages

  24. Paternal body fat mass

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in percentages

  25. Paternal body lean mass

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in percentages

  26. Paternal body visceral fat

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    Determined from body fat analysis in percentages

  27. Paternal health and general well-being - self assessment

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From questionnaires

  28. Paternal health and general well-being

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From digital sensor

  29. Paternal immunological profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood and/or urine samples

  30. Paternal biochemical profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood and/or urine samples

  31. Paternal metabolic profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood and/or urine samples

  32. Paternal molecular profile

    Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum

    From blood and/or urine samples

  33. Breast milk macronutrient profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  34. Breast milk micronutrient profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  35. Breast milk immune factor profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  36. Breast milk epigenetic profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  37. Breast milk biochemical profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  38. Breast milk metabolic profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  39. Breast milk microbiome profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  40. Breast milk molecular profile (subsample)

    Time frame: Up to 1 year, between date of delivery and 1 year postpartum

    From breast milk sample

  41. Maternal transcriptomics

    Time frame: Up to 36 months, between preconception, pregnancy and 1 year postpartum

    From blood and/or breast milk samples

  42. Infant transcriptomics

    Time frame: Up to 36 months, between preconception, pregnancy and 1 year postpartum

    From blood

Study contacts

Contact information is provided by the study sponsor or research team.

Lan Tian Lai, MSc

CONTACT

[email protected]

Xiang Wen Ng, MPH

CONTACT

[email protected]

+65 6394 8113

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Lien Foundation

Registry information

Acronym: HELMS

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jan 26, 2022
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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