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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age6-8
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Family-Based Treatment (FBT)

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Seattle Children's Hospital

Collaborator

Rush University Medical Center

Collaborator