Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks
2 other identifiers
interventional
240
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
Study Completion
Last participant's last visit for all outcomes
June 1, 2030
March 10, 2026
March 1, 2026
3.7 years
March 3, 2026
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pubertal onset (gonadarche)
The proportion of girls who experience pubertal onset (onset vs. no onset) in the intervention vs. control conditions will be examined at the 18- and 30-month post-randomization FUs. Gonadarche will be indexed by a hormonal indicator LH, coded dichotomously (pubertal status \>0.3 IU/L vs. prepubertal status ≤0.3 IU/L) and Tanner stage (TS) breast development, coded dichotomously (pubertal status=TS2 or greater vs. prepubertal status=TS1).
18 months, 30 months
Pubertal onset (adrenarche)
The proportion of girls who experience pubertal onset (onset vs. no onset) in the intervention vs. control conditions will be examined at the 18- and 30-month post-randomization FUs. Adrenarche will be indexed by a hormonal indicator DHEAS, coded dichotomously (pubertal status \>40 ug/dl vs. prepubertal status ≤40 ug/dl) and Tanner stage (TS) pubic hair development, coded dichotomously (pubertal status=TS2 or greater vs. prepubertal status=TS1).
18 months, 30 months
Secondary Outcomes (3)
Pubertal onset (gonadarche and adrenarche)
18 months, 30 months
Pubertal onset (gonadarche and adrenarche)
Baseline, 6 months, 18 months, 30 months (4x hormones and questionnaires available); Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months (7x questionnaires available)
Pubertal onset (gonadarche)
Baseline, 6 months, 18 months, 30 months
Study Arms (2)
Family-Based Treatment (FBT) Condition
EXPERIMENTALBehavioral treatment program provides treatment to reduce weight and improve lifestyle behaviors.
Enhanced Control Condition
NO INTERVENTIONEnhanced control condition provides educational materials about healthy eating and physical activity behaviors.
Interventions
The FBT intervention entails 20 weekly sessions (30 min each) with girls and their families and 20 corresponding parent-only group sessions (40 min each). The family sessions provide protocol-based tailored support for behavioral skills related to family eating and physical activity change and focus on feedback, accountability, and problem solving for skill use and barriers and goal-setting specific to each family. The parent only group sessions provide education focused on behavior change as well as guidance focused on parenting in areas of healthy eating and active living. Treatment components will include a Healthy Eating Plan (Stoplight Eating Plan), Physical Activity Goals, and Behavioral Skills.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Family lives in temporary or group housing or has plans to relocate outside the Seattle metropolitan area in the next 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Seattle Children's Hospitalcollaborator
- Rush University Medical Centercollaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Bleil, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate Professor, School of Nursing
Study Record Dates
First Submitted
March 3, 2026
First Posted
March 10, 2026
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be made available as soon as possible after the data collection period has ended and will occur no later than the end of the project period or the time of any publication. Data will remain available for a period of at least 10 years, or indefinitely if possible.
- Access Criteria
- The project generated data and metadata will be archived in the OSF, an NIH-recommended generalist repository, member of the NIH Generalist Repository Ecosystem Initiative (GREI), which meets the NIH's Desirable Characteristics for Data Repositories. As a public dataset on OSF, the data will receive a persistent identifier through registration of a DOI with Datacite, and with rich metadata using the Datacite metadata schema. The metadata for the OSF data will follow the OSF metadata profile, which maps to the Datacite community-developed metadata schema, which includes title, description, authors, license, subject, language, resource type, publication date, modification date. Access to the OSF public log data is made accessible through the OSF API which is licensed under Apache 2.0 and in the public domain for use.
Demographic, health behaviors, and health status data will be collected from 240 girls and their families. Sources of data will include anthropometrics, skin carotenoids, actigraphy, blood pressure, blood draw, acanthosis nigricans ratings, and questionnaires. We plan to share the research data to the greatest extent possible, although there are a few considerations that will require limiting the type and amount of data shared. Certain combinations of data (geography) will not be provided due to the possibility of deducing a participant's identity. All data will be completely de-identified prior to sharing. All identification covered under HIPAA will be removed. All remaining variables not covered under HIPAA will be evaluated in terms of the risk of deductive disclosure of identity, and measures will be taken to protect confidentiality. Data sharing plans will be fully described in the informed consent documents for the study.