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Family lifestyle program may delay early puberty in at-risk girls

NCT ID NCT07460544

Disease control Sponsor: University of Washington 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a family-based weight management program can slow the start of puberty in girls aged 6.5 to 8 years who have overweight or obesity. Half of the 240 girls will join a 20-session program focused on healthy eating and activity, while the other half receive usual care. Researchers will track puberty signs over 3 years to see if the program makes a difference.

What this could mean

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

Active substance
Family-Based Treatment (FBT) - a behavioral program focusing on healthy eating and physical activity
What this could lead to
If successful, this approach could help delay early puberty in girls with higher weight, potentially reducing risks for later health problems like heart disease and mental health issues.
What could go wrong
This is an early-stage study with 240 participants, so results may not apply to all girls. The program requires a big time commitment, and it's unclear if benefits will last long-term.

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 240 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

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.

Ages

6 to 8 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: 1. Child female biological sex 2. Child BMI percentile in the overweight/obese range (BMI percentile ≥85th for age and sex) 3. Low child household income based on local income requirements for subsidized housing 4. At least 50% enrollment of child Black or Latina or 'multiple' race or ethnicity identification (self- or mother-identified) 5. Child between ages 6.5 and 8.0 years at screening 6. Participation of child with mother who identifies as a primary caregiver 7. Confirmed child prepubertal status by mother-report on the indicated pubertal staging scale 8. Child and mother speak English 9. Successful completion of the 'run-in' protocol, which includes screening and the baseline assessment Exclusion Criteria: 1. Child has medical contraindications to participate in a weight loss program (e.g., chromosomal abnormality, phenylketonuria, syndromal cause of obesity, type 1 diabetes) as determined by child's pediatrician or study pediatrician 2. Mother has major medical or psychiatric conditions likely to interfere with participation (e.g., dementia, schizophrenia, terminal illness with life expectancy \<12 months) 3. Family lives in temporary or group housing or has plans to relocate outside the Seattle metropolitan area in the next 12 months

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Conditions

The condition(s) this trial relates to.

Health Behavior Obesity obesity disorder Overweight Weight Loss

As listed by the trial registrant

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

Cardiometabolic health Health behavior Overweight/obesity Puberty

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Washington

    Seattle, Washington, 98195, United States

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