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One weight gain target may not fit all: a massive study asks if obesity severity changes the safest range.

NCT ID NCT07796815

Knowledge-focused Sponsor: Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This observational study looks at health data from about 10 million U.S. birth records to find the safest amount of weight gain during pregnancy for women with obesity. Current guidelines recommend the same 5 to 9 kg gain for all, but obesity has different levels of severity. Researchers will compare eight weight gain ranges across three obesity classes to see which ranges are linked to fewer complications for mothers and babies. The goal is to find specific targets for each class to lower risks like ICU stays, high blood pressure, and babies born too large or too small.

What this could mean

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

Active substance
Gestational weight gain (behavioral intervention)
What this could lead to
If successful, this could lead to personalized weight gain targets for each class of obesity, reducing pregnancy complications for mothers and newborns.
What could go wrong
This is an observational study, so it can show associations but not prove cause and effect. The results depend on the accuracy of birth records and may not apply to all populations.

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.

Participants

1,600,000 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population comprises all individuals with a documented live birth in the United States between January 1, 2023, and December 31, 2025, whose records are captured in the National Vital Statistics System (NVSS) natality files. The NVSS is a nationwide, population-based registry maintained by the National Center for Health Statistics (NCHS), covering nearly 100% of U.S. births. All data are de-identified and publicly available through the CDC's website. Participants are drawn from all 50 states and the District of Columbia, representing diverse geographic regions, racial/ethnic groups, and socioeconomic backgrounds. This secondary analysis uses only existing administrative and health records reported on birth certificates; no direct contact with participants occurs.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Nulliparous or multiparous individuals aged 18 to 45 years at delivery. Singleton, live-born, term pregnancy (37 to 41 completed weeks of gestation). Pre-pregnancy obesity, defined as body mass index (BMI) ≥ 30.0 kg/m². Initiation of prenatal care during the first trimester (months 1-3 of pregnancy). Exclusion Criteria: * Missing data on pre-pregnancy weight, delivery weight, or birth weight. Implausible gestational weight gain (GWG) values: \< -10 kg or \> 50 kg. Unknown mode of delivery or documented prior cesarean section.

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Conditions

The condition(s) this trial relates to.

Gestational Weight Gain obesity disorder pregnancy disorder Pregnancy in Obesity

As listed by the trial registrant

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

Gestational weight gain Pregnancy in obesity

Contacts and locations

Locations

  • National Vital Statistics System (NVSS) - United States

    Hyattsville, Maryland, 20782, United States

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