A Phase 1 interventional study of Clinic + Home Behavioral Intervention and Pediatrician Counseling in Obesity, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-22.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1, Interventional, and Treatment
The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.
H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
Behavioral: Clinic Only Behavioral Intervention
A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
Other: Pediatrician Counseling
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.
Behavioral: Clinic + Home Behavioral Intervention
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.
A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
Change in BMI z score
Body mass index z score
Time frame: Change from Baseline to 6 months
Change in Parent weight loss
Time frame: Change from baseline to 6 months
Change in Child caloric intake
Time frame: Change from baseline to 6 months
Change in Home food and activity environment
Time frame: Change from baseline to 6 months
Change in Child physical activity
Time frame: Change from baseline to 6 months
Change in Parent-child mealtime interactions
Time frame: Change from baseline to 6 months
Change in Health related quality of life
Time frame: Change from baseline to 6 months
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati