Behavioral Rx & Nutrition in Pediatric Chronic Disease

Pediatric Obesity Clinical Trial

— LAUNCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018121
• Other study ID #: 103254
• Secondary ID: K24DK059492
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 19, 2009
• Last updated: November 20, 2009
• Start date: November 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Obesity

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.

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z score		Baseline, 6 months, 12 months	Yes
Secondary	Parent weight loss		baseline, 24 weeks, 48 weeks	No
Secondary	Child caloric intake		baseline, 6 months, 12 months	No
Secondary	Home food and activity environment		baseline, 6 months, 12 months	No
Secondary	Child physical activity		baseline, 6 motnhs, 12 months	No
Secondary	Parent-child mealtime interactions		baseline, 6 months, 12 months	No