Improving Health in Disadvantaged Girls to Slow Puberty
This study is looking at whether a program called Family-Based Treatment (FBT) can help slow down when puberty starts in girls who are overweight or obese and come from disadvantaged families. FBT involves weekly sessions for girls and their families, focusing on healthy eating and physical activity. Researchers believe that helping girls achieve a healthy weight and lifestyle before puberty might delay its onset. This is important because starting puberty earlier can sometimes lead to other health challenges later in life. The study will compare girls who receive FBT to those who don't, to see if FBT can make a difference in when puberty begins. You may be able to join if you are a girl between 6.5 and 8 years old, are overweight or obese, and your family has a low income.
- Study design
- This is an interventional study planning to enroll 240 female participants. Half of the girls will participate in a treatment program, and half will be in a control group.
- What's involved
- The Family-Based Treatment involves 20 weekly sessions (30 minutes each) with girls and their families, and 20 parent-only group sessions (40 minutes each).
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure pubertal onset at 18 months and 30 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Maria Bleil, PhD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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What this trial measures
- 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).