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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Family-Based Treatment (FBT)
BehavioralThe 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Family-Based Treatment (FBT) ConditionExperimental treatment 1 intervention
Group B: Enhanced Control ConditionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
18 months, 30 months2
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).
Time frame
18 months, 30 monthsSecondary outcomes
1
Pubertal onset (gonadarche and adrenarche)
In secondary analyses, pubertal onset in the intervention vs. control conditions will also be examined at the 18- and 30-month post-randomization FUs examining hormonal indicators continuously with higher LH values indicating gonadarche and higher DHEAS values indicating adrenarche.
Time frame
18 months, 30 months2
Pubertal onset (gonadarche and adrenarche)
In secondary analyses, patterns of change in the pubertal onset outcomes (for hormonal indicators and Tanner staging questionnaires) will be examined from baseline to the 36-month post randomization FUs. Mixed logistic regression models (for binary outcomes) or linear mixed models (for continuous outcomes) that include a time by treatment interaction will be used.
Time frame
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)3
Pubertal onset (gonadarche)
In secondary analyses, E2 will be examined as an alternative hormonal indicator of gonadarche using the same analytical strategies described above (dichotomous, continuous, and patterns of change examined over time).
Time frame
Baseline, 6 months, 18 months, 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
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