Integrated care for overweight women before, during, and after pregnancy
Healthy Early Life Moments in Singapore
This study is testing a program that helps overweight women improve their health before, during, and after pregnancy to see if it leads to better outcomes for them and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 21 Years to 40 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05207059 on ClinicalTrials.gov |
What this trial studies
This study evaluates an integrated continuum of care aimed at improving metabolic and mental health outcomes for overweight and obese women from the preconception period through the first 18 months postpartum. The Healthy Early Life Moments in Singapore (HELMS) program will enroll 500 women aged 21-40 years who plan to conceive, providing them with lifestyle guidance on diet, physical activity, emotional well-being, and sleep. Participants will undergo various assessments and biosample collections to monitor health changes and the effectiveness of the intervention over five years. The goal is to break the cycle of obesity transmission and promote healthier life cycles for mothers and their children.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese women aged 21-40 years planning to conceive within a year and residing in Singapore.
Not a fit: Patients who are currently pregnant or have certain medical conditions such as diabetes or are on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the health of mothers and their children, reducing the risk of obesity and mental health issues.
How similar studies have performed: Other studies have shown promise in similar lifestyle interventions for maternal health, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Jerry Chan, MB BCh BaO MA FRCOG PhD — KK Women's and Children's Hospital
- Study coordinator: Xiang Wen Ng, MPH
- Email: ng.xiang.wen@kkh.com.sg
- Phone: +65 6394 8113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.