Behavioral Rx & Nutrition in Pediatric Chronic Disease (LAUNCH)

LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: LAUNCH; Other: Pediatrician Counseling

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinic and Home Behavioral Intervention	Behavioral: LAUNCH; 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.
Active Comparator: Pediatrician Counseling	Other: Pediatrician Counseling; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMI z score	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Child physical activity	baseline, 6 motnhs, 12 months
Parent-child mealtime interactions	baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Lori J Stark, Ph.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: November 19, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (Estimate): November 23, 2009

Study Record Updates

• Last Update Posted (Estimate): November 23, 2009
• Last Update Submitted That Met QC Criteria: November 20, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Behavioral Treatment; Obesity Treatment; Preschool Children
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 103254; K24DK059492 (U.S. NIH Grant/Contract)