Behavioral Treatment for Obese Preschoolers (LAUNCH)
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ClinicalTrials.gov Identifier: NCT01546727 |
Recruitment Status :
Completed
First Posted : March 7, 2012
Last Update Posted : December 28, 2016
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Behavioral: Behavioral Family Intervention Behavioral: Motivational Interviewing | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 167 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
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Experimental: Family Behavioral Treatment
This intervention will provide nutritional counseling for a health diet, parent training in effective child behavioral management strategies, and stimulus control of the home environment delivered via group based clinic visits and individual home visits on alternate weeks
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Behavioral: Behavioral Family Intervention
Three months of weekly treatment delivered via alternating group based clinic visits and individual home visits followed by three months of every other week treatment alternating between clinic and home.
Other Name: LAUNCH |
Active Comparator: Motivational Interviewing
This intervention will shared information with parents about their child's weight and use motivational interviewing to elicit changes parents would like to make to their child diet and activity patterns.
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Behavioral: Motivational Interviewing
Motivational interviewing will be delivered at the same frequency at the behavioral intervention with 4 in-person visits spaced at the first visit, month 3 and month 5. Phone calls will be conducted weekly during the first 3 months and every other week during months 4 through 6.
Other Name: MI |
No Intervention: Standard of Care
Participants in this arm will be followed over time and be assessed on the primary and secondary outcomes at the same time points as the two treatment arms
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- Change in BMIz score [ Time Frame: Baseline to 6 months ]Body Mass Index z-score
- Change in BMI z at follow up [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
- Change in Caloric Intake [ Time Frame: Baseline, 6 months, 12 months, 18 months ]Three 24 hour dietary recalls at each time point
- Change in Physical Activity [ Time Frame: Baseline, 6 months, 12 months, 18 months ]Physical Activity will be measured using Accelermeters set in 15 sec epochs
- Change in home health environment [ Time Frame: Baseline, 6 months, 12 months, 18 months ]Home observation recording of food (e.g.,fruits, vegetables, high calorie foods and beverages)and presence of TV in child's bedroom
- Changes in parent calorie intake [ Time Frame: Baseline, 6 months, 12 months, 18 months ]Will assess using Block 2005 Food Frequency
- Changes in parent physical activity [ Time Frame: Baseline, 6 months, 12 months, 18 months ]Will be assessed using the Paffenbarger Activity Questionnaire for calorie expenditure
- Parenting and Child Eating Behaviors [ Time Frame: Baseline, 6 month, 12 months, 18 months ]Will assess using Parenting Styles and Dimensions, About Your Child's Eating - Revised, and Child Feeding Questionnaire
- Change in Health Related Quality of Life [ Time Frame: Baseline, 6 months, 12 months, 18 months ]Will be assessed using the PedQL

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Ages Eligible for Study: | 2 Years to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children ages 2 years 0 months to 5 years 11 months
- BMI percentile at or above the 95th percentile for age- and gender, but no more than 100% above the median BMI for age and gender.
- English-speaking
- Live within 50 miles of Cincinnati Children's Hospital Medical Center (CCHMC)
- Medical clearance from the child's pediatrician to participate.
Exclusion Criteria:
- Medical conditions known to promote obesity (e.g., Prader-Willi syndrome, Cushing's syndrome)
- Already involved with another weight control program
- Taking weight-affecting medications (e.g., steroids).
- A disability or illness that would preclude them from engaging in at least moderate intensity physical activity
- Developmental disability

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 ClinicalTrials.gov identifier (NCT number): NCT01546727
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | Lori J Stark, Ph.D. | Children's Hospital Medical Center, Cincinnati |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT01546727 History of Changes |
Other Study ID Numbers: |
R01DK091251 ( U.S. NIH Grant/Contract ) 1R01DK091251-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | March 7, 2012 Key Record Dates |
Last Update Posted: | December 28, 2016 |
Last Verified: | December 2016 |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Preschoolers Obesity Behavioral Treatment |