Clinical trial

Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks

Opening soon · Not applicable · 1 countries · Registry ID NCT07460544

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 8 Years

SexFemale

Healthy volunteersNot accepted

ConditionOverweight/Obesity, Puberty, Health Behavior, Cardiometabolic Health

Full registry criteria

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

Treatments and study arms

Family-Based Treatment (FBT)

Behavioral

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.

Primary outcomes

Pubertal onset (gonadarche)18 months, 30 months

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).

Pubertal onset (adrenarche)18 months, 30 months

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).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Washington🇺🇸 Seattle, Washington, United States

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