Clinical trial

Healthy Early Life Moments in Singapore

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05207059

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 40 Years

SexFemale

Healthy volunteersAccepted

ConditionMetabolic Disease, Mental Health Wellness 1, Lifestyle Risk Reduction, Maternal Obesity

Full registry criteria

Inclusion Criteria: 1. Women aged 21-40 years 2. BMI 25-40 kg/m2 3. Intention to reside in Singapore for the next 4 years 4. Chinese, Malay, Indian or any combination of these 3 ethnic groups 5. Planning to conceive within 1 year 6. Able to understand English 7. Able to provide written, informed consent Exclusion Criteria: 1. Currently pregnant 2. Known type 1 or type 2 diabetes 3. On any anticonvulsant medication in the past 1 month 4. On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron) 5. On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month 6. On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene/ Letrozole in the past 1 month 7. On HIV or Hepatitis B or C medication in the past 1 month.

Treatments and study arms

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

Pregnancy rateUp to 12 months

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

Maternal metabolic healthUp to 40 months, between preconception, pregnancy and 18 months postpartum

Evaluated by metabolic syndrome criteria

Maternal mental healthUp 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

KK Women's and Children's Hospital🇸🇬 Singapore, Singapore

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