Behavioral Rx & Nutrition in Pediatric Chronic Disease (LAUNCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018121
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : November 23, 2009
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by:
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: LAUNCH Other: Pediatrician Counseling Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
Study Start Date : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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

Primary Outcome Measures :
  1. BMI z score [ Time Frame: Baseline, 6 months, 12 months ]

Secondary Outcome Measures :
  1. Parent weight loss [ Time Frame: baseline, 24 weeks, 48 weeks ]
  2. Child caloric intake [ Time Frame: baseline, 6 months, 12 months ]
  3. Home food and activity environment [ Time Frame: baseline, 6 months, 12 months ]
  4. Child physical activity [ Time Frame: baseline, 6 motnhs, 12 months ]
  5. Parent-child mealtime interactions [ Time Frame: baseline, 6 months, 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01018121

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Principal Investigator: Lori J Stark, Ph.D. Children's Hospital Medical Center, Cincinnati

Responsible Party: Lori J. Stark Director of Behavioral Medicine and Clinical Psychology, Children's Hospital Medical Center, Cincinnati Identifier: NCT01018121     History of Changes
Other Study ID Numbers: 103254
K24DK059492 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

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

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