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Can a Pre-Pregnancy lifestyle program boost mother and child health?

NCT ID NCT05207059

Prevention Sponsor: KK Women's and Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether a comprehensive lifestyle program, called HELMS, can improve the health of overweight women and their children. The program starts before conception and continues through pregnancy and the first 18 months of the child's life, including health screenings, weight management, supplements, and personalized care. Researchers will measure pregnancy rates, maternal metabolic and mental health, and child development. The study involves 500 women aged 21-40 with a BMI between 25 and 40 who plan to conceive within a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A behavioral lifestyle intervention called HELMS, which includes screening, weight management, supplementation, and case management from before conception through 18 months after birth.
What this could lead to
If successful, this could establish a practical care model to reduce obesity-related complications in pregnancy and improve health outcomes for mothers and children.
What could go wrong
The trial is early and the intervention is complex, so results may not show clear benefits. Participation requires commitment over several years, and outcomes may vary among individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metabolic disease Obesity Pregnancy in Obesity Psychological Well-Being Risk Reduction Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lifestyle risk reduction Maternal obesity Mental health wellness 1 Metabolic disease

Contacts and locations

Locations

  • KK Women's and Children's Hospital

    Singapore, 229899, Singapore

More trials for these conditions

Other studies related to the condition(s) this trial covers.