Pediatric Obesity
Conditions
Keywords
Behavioral Treatment, Preschool Children, Obesity Treatment
Brief summary
The objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is: H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.
Interventions
BEHAVIORALLAUNCH
A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions. Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.
A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children
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
1. child age between 2- 5 years; 2. child \> 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI; 3. medical clearance from pediatrician; and 4. at least one parent with a BMI \> 25. -
Exclusion criteria
1. non-English speaking; 2. living more than 50 miles from the medical center; 3. a disability/illness that would preclude engagement in at least moderate physical activity; 4. medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI z score | Baseline, 6 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Child physical activity | baseline, 6 motnhs, 12 months |
| Parent weight loss | baseline, 24 weeks, 48 weeks |
| Child caloric intake | baseline, 6 months, 12 months |
| Home food and activity environment | baseline, 6 months, 12 months |
| Parent-child mealtime interactions | baseline, 6 months, 12 months |
Countries
United States
Outcome results
None listed