RecruitingNot ApplicableNCT05207059

Healthy Early Life Moments in Singapore

Sponsor

KK Women's and Children's Hospital

Enrollment

500 participants

Start Date

Mar 18, 2022

Study Type

INTERVENTIONAL

Conditions

Metabolic Disease Lifestyle Risk Reduction Mental Health Wellness 1

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.

Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 40 Years

Inclusion Criteria7

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 Criteria7

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.

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Interventions

BEHAVIORALHELMS Lifestyle Intervention

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.