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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 8 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Pubertal onset will be indexed both by hormones and questionnaire-based pubertal staging methods to characterize the initiation of the main pubertal development processes: 1) gonadarche (i.e., luteinizing hormone \[LH\], Tanner stage 2 \[TS2\] breast) and 2) adrenarche (i.e., dehydroepiandrosterone sulfate \[DHEAS\], TS2 pubic hair)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a family program for healthy eating, activity, and weight loss can delay the start of puberty. It is for girls ages 6½ to 8 from low-income homes who have a high weight for their age and have not started puberty. Half will join the program, and half will get usual medical care and health handouts.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Child is female by biological sex and is ages 6½ to 8 at screening.
  • Child has a body mass index (BMI), a measure of weight compared with height, at or above the 85th percentile for age and sex.
  • Household income meets local low-income rules for housing aid.
  • The study aims for at least half of enrolled girls to be Black, Latina, or of more than one race or ethnicity, as reported by the child or mother.
  • Child joins with her mother, who is a main caregiver.
  • Mother's answers on a puberty checklist confirm that the child has not started puberty.
  • Child and mother speak English.
  • Family completes the required screening and first study assessment.

Who can't join

  • Child has a health condition that makes a weight-loss program unsafe, as decided by her doctor or the study's child doctor. Examples include type 1 diabetes and certain genetic or food-processing disorders.
  • Mother has a serious physical or mental health condition that would likely prevent participation, such as dementia, schizophrenia, or a terminal illness with less than 12 months to live.
  • Family lives in temporary or group housing, or plans to move outside the Seattle area within 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

WA