Healthy Early Life Moments in Singapore (HELMS)

KK Women's and Children's Hospital

Status: Enrolling

Conditions: Maternal Obesity; Lifestyle Risk Reduction; Mental Health Wellness 1; Metabolic Disease

Treatments: Behavioral: HELMS Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05207059

2021/2247

Details and patient eligibility

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Study Arm

Experimental group

Description:

The intervention will comprise four modules, namely the HELMS Journey, HELMS Model, HELMS Lifestyle and HELMS Community. The HELMS Journey will provide anticipatory guidance for both HELMS and routine clinic visits. The HELMS Model will deliver the 4S ('Screening', 'Size', 'Supplementation' and 'Specific case management') care plan, detailed below. The HELMS Lifestyle will provide lifestyle support in terms of healthy eating through the 6P tool ('Portion', 'Proportion', 'Pleasure', 'Phase', Physicality', 'Psychology'), physical activity, sleep and mental well-being. Finally, the HELMS Connection will provide community support and improve engagement with the program.

Treatment:

Behavioral: HELMS Lifestyle Intervention