Behavioral Rx & Nutrition in Pediatric Chronic Disease (LAUNCH)
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LAUNCH
Pediatrician Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring Behavioral Treatment, Preschool Children, Obesity Treatment
Eligibility Criteria
Inclusion Criteria:
- child age between 2- 5 years;
- child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
- medical clearance from pediatrician; and
- at least one parent with a BMI > 25. -
Exclusion Criteria:
- non-English speaking;
- living more than 50 miles from the medical center;
- a disability/illness that would preclude engagement in at least moderate physical activity;
- medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clinic and Home Behavioral Intervention
Pediatrician Counseling
Arm Description
Outcomes
Primary Outcome Measures
BMI z score
Secondary Outcome Measures
Parent weight loss
Child caloric intake
Home food and activity environment
Child physical activity
Parent-child mealtime interactions
Full Information
NCT ID
NCT01018121
First Posted
November 19, 2009
Last Updated
November 20, 2009
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT01018121
Brief Title
Behavioral Rx & Nutrition in Pediatric Chronic Disease
Acronym
LAUNCH
Official Title
LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Behavioral Treatment, Preschool Children, Obesity Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinic and Home Behavioral Intervention
Arm Type
Experimental
Arm Title
Pediatrician Counseling
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
LAUNCH
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pediatrician Counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
BMI z score
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Parent weight loss
Time Frame
baseline, 24 weeks, 48 weeks
Title
Child caloric intake
Time Frame
baseline, 6 months, 12 months
Title
Home food and activity environment
Time Frame
baseline, 6 months, 12 months
Title
Child physical activity
Time Frame
baseline, 6 motnhs, 12 months
Title
Parent-child mealtime interactions
Time Frame
baseline, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
child age between 2- 5 years;
child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
medical clearance from pediatrician; and
at least one parent with a BMI > 25. -
Exclusion Criteria:
non-English speaking;
living more than 50 miles from the medical center;
a disability/illness that would preclude engagement in at least moderate physical activity;
medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori J Stark, Ph.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Rx & Nutrition in Pediatric Chronic Disease
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