Obesity
Conditions
Keywords
Behavioral treatment, Preschool aged children, Obesity
Brief summary
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.
Interventions
BEHAVIORALClinic + 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.
BEHAVIORALClinic Only Behavioral Intervention
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* 2 years 0 months to 5 years 11 months of age * at or above the 95th percentile BMI for age and sex * have at least one parent with a BMI at or greater than 25 * medical clearance from pediatrician
Exclusion criteria
* non-English speaking * living greater than 50 miles from medical center * a disability or illness that would preclude engagement in moderate activity * medical condition/medication associated with weight * enrolled in another weight management program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI z score | Change from Baseline to 6 months | Body mass index z score |
Secondary
| Measure | Time frame |
|---|---|
| Change in Child caloric intake | Change from baseline to 6 months |
| Change in Home food and activity environment | Change from baseline to 6 months |
| Change in Parent weight loss | Change from baseline to 6 months |
| Change in Parent-child mealtime interactions | Change from baseline to 6 months |
| Change in Health related quality of life | Change from baseline to 6 months |
| Change in Child physical activity | Change from baseline to 6 months |
Countries
United States
Outcome results
None listed