Healthy Early Life Moments in Singapore

ConditionsMetabolic Disease Mental Health Wellness 1 Lifestyle Risk Reduction Maternal Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age21-40

SponsorKK Women's and Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Study ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KK Women's and Children's Hospital

Lead sponsor

Lien Foundation

Collaborator

Source ClinicalTrials.gov

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