Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks (NCT07460544) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks
United States240 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range6 Years ā 8 Years
SexFEMALE
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Inclusion criteria
ā. Child female biological sex
ā. Child BMI percentile in the overweight/obese range (BMI percentile ā„85th for age and sex)
ā. Low child household income based on local income requirements for subsidized housing
ā. At least 50% enrollment of child Black or Latina or 'multiple' race or ethnicity identification (self- or mother-identified)
ā. Child between ages 6.5 and 8.0 years at screening
ā. Participation of child with mother who identifies as a primary caregiver
ā. Confirmed child prepubertal status by mother-report on the indicated pubertal staging scale
ā. Child and mother speak English
Exclusion criteria
ā. 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
ā. Mother has major medical or psychiatric conditions likely to interfere with participation (e.g., dementia, schizophrenia, terminal illness with life expectancy \<12 months)
ā. Family lives in temporary or group housing or has plans to relocate outside the Seattle metropolitan area in the next 12 months