Behavioral Rx & Nutrition in Pediatric Chronic Disease (LAUNCH)

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01018121
First received: November 19, 2009
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Pediatric Obesity
Behavioral: LAUNCH
Other: Pediatrician Counseling
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • BMI z score [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Parent weight loss [ Time Frame: baseline, 24 weeks, 48 weeks ] [ Designated as safety issue: No ]
  • Child caloric intake [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Home food and activity environment [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Child physical activity [ Time Frame: baseline, 6 motnhs, 12 months ] [ Designated as safety issue: No ]
  • Parent-child mealtime interactions [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018121

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Lori J Stark, Ph.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Lori J. Stark Director of Behavioral Medicine and Clinical Psychology, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01018121     History of Changes
Other Study ID Numbers: 103254, K24DK059492
Study First Received: November 19, 2009
Last Updated: November 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Behavioral Treatment
Preschool Children
Obesity Treatment

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014