NCT07460544Not yet recruiting
Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
This study is testing whether improving health in girls during the prepubertal period may slow the onset of puberty. This study will focus on prepubertal girls who have a high weight status (at or above the 85th percentile for body mass index). Half of the girls who join the study will participate in a treatment program to reduce weight and improve lifestyle behaviors, and half of the girls will participate in a control condition. The frequency of pubertal onset will be compared across the groups. This research is important because girls who experience puberty at an earlier age are at risk for poor psychological and physical health. Girls in the treatment condition will participate in the Family Based Treatment (FBT) program, an established treatment for children who are overweight or obese. Families attend 20 weekly sessions (30 minutes each) over a 5-month period. Sessions are led by a trained interventionist and focus on healthy eating and physical activity behaviors. Girls in the control condition will receive their usual medical care through their pediatric care doctor or other care provider. Families will also receive educational handouts about 1 time per month, addressing topics related to healthy eating and physical activity behaviors. Families in both the treatment and control conditions will participate in assessments conducted at baseline and approximately 6-, 12-, 18-, 24-, 30-, and 36 months follow-up. These assessments are led by a data collector and include the measurement of height and weight, pubertal status, and health behaviors.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 3 Mar 2026
- Start date
- May 2026
- Primary completion date
- Jan 2030
- Lead sponsor
- University of Washington
- Diseases
- Obesity
- NCT number
- NCT07460544
What you commit to
- Study type: Interventional
- Planned participants: 240
- From May 2026 to the primary completion date, Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Mother has major medical or psychiatric conditions likely to interfere with participation (e.g., dementia, schizophrenia, terminal illness with life expectancy \<12 months)
Other
- Family lives in temporary or group housing or has plans to relocate outside the Seattle metropolitan area in the next 12 months
Who the study is looking for
- Child female biological sex
- Child BMI percentile in the overweight/obese range (BMI percentile ≥85th for age and sex)
- Low child household income based on local income requirements for subsidized housing
- At least 50% enrollment of child Black or Latina or 'multiple' race or ethnicity identification (self- or mother-identified)
- Child between ages 6.5 and 8.0 years at screening
- Participation of child with mother who identifies as a primary caregiver
- Confirmed child prepubertal status by mother-report on the indicated pubertal staging scale
- Child and mother speak English
- Successful completion of the 'run-in' protocol, which includes screening and the baseline assessment
Age in the registry: 6 years to 8 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.