Behavioral Treatment for Obese Preschoolers
Completed · Phase 3
Conditions studied: Obesity
In brief
This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (\>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. The investigators will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).
Key facts
- Study ID
- NCT01546727
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 167
- Starts
- 2012-03-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2016-12-28
Who can join
Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children ages 2 years 0 months to 5 years 11 months
- BMI percentile at or above the 95th percentile for age- and gender, but no more than 100% above the median BMI for age and gender.
- English-speaking
- Live within 50 miles of Cincinnati Children's Hospital Medical Center (CCHMC)
- Medical clearance from the child's pediatrician to participate.
You may not qualify if…
- Medical conditions known to promote obesity (e.g., Prader-Willi syndrome, Cushing's syndrome)
- Already involved with another weight control program
- Taking weight-affecting medications (e.g., steroids).
- A disability or illness that would preclude them from engaging in at least moderate intensity physical activity
- Developmental disability
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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