Metabolic DiseaseMental Health Wellness 1Lifestyle Risk ReductionMaternal Obesity
Investigational drug(s) / intervention(s)
HELMS Lifestyle Intervention
HELMS 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.
Study 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
FEMALE
Min age
21 Years
Max age
40 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Pregnancy rate — Up to 12 months Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages
Maternal metabolic health — Up to 40 months, between preconception, pregnancy and 18 months postpartum Evaluated by metabolic syndrome criteria
Maternal mental health — 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
Trial sites (1)
Facility
City
Region
Status
KK Women's and Children's Hospital
Singapore
Singapore
More KK Women's and Children's Hospital trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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