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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07460544
Status
Not Yet Recruiting

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Conditions

  • Cardiometabolic Health
  • Health Behavior
  • Overweight/Obesity
  • Puberty

Eligibility Criteria

Sex
FEMALE
Age
6 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Family-Based Treatment (FBT) Condition
    Behavioral treatment program provides treatment to reduce weight and improve lifestyle behaviors.
  • No Intervention: Enhanced Control Condition
    Enhanced control condition provides educational materials about healthy eating and physical activity behaviors.

Primary Outcome Measure

Pubertal onset (gonadarche) [ Time Frame: 18 months, 30 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195-

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By research site
University of Washington· Seattle, WA

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