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| ID | Type | Description | Link |
|---|---|---|---|
| K24DK059492 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic and Home Behavioral Intervention | Experimental |
| |
| Pediatrician Counseling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAUNCH | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI z score | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent weight loss | baseline, 24 weeks, 48 weeks | |
| Child caloric intake | baseline, 6 months, 12 months | |
| Home food and activity environment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori J Stark, Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D018531 | Spacecraft |
| ID | Term |
|---|---|
| D013026 | Space Flight |
| D001359 | Aviation |
| D014186 | Transportation |
| D013676 | Technology, Industry, and Agriculture |
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|
| Pediatrician Counseling | Other | 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 |
|
| baseline, 6 months, 12 months |
| Child physical activity | baseline, 6 motnhs, 12 months |
| Parent-child mealtime interactions | baseline, 6 months, 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |