Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborators:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01419951
First received: August 5, 2011
Last updated: November 16, 2012
Last verified: August 2011
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Purpose
The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.
H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: Clinic + Home Behavioral Intervention Other: Pediatrician Counseling Behavioral: Clinic Only Behavioral Intervention |
Phase 1 |
| 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:
- Change in BMI z score [ Time Frame: Change from Baseline to 6 months ] [ Designated as safety issue: Yes ]Body mass index z score
Secondary Outcome Measures:
- Change in Parent weight loss [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- Change in Child caloric intake [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: Yes ]
- Change in Home food and activity environment [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- Change in Child physical activity [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- Change in Parent-child mealtime interactions [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- Change in Health related quality of life [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Clinic Only Behavioral Intervention
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
|
Behavioral: Clinic Only Behavioral Intervention
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
|
|
Active Comparator: Pediatrician Counseling
A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
|
Other: Pediatrician Counseling
A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
|
|
Experimental: Clinic + Home Behavioral Intervention
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.
|
Behavioral: Clinic + Home Behavioral Intervention
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.
|
Eligibility| Ages Eligible for Study: | 2 Years to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 2 years 0 months to 5 years 11 months of age
- at or above the 95th percentile BMI for age and sex
- have at least one parent with a BMI at or greater than 25
- medical clearance from pediatrician
Exclusion Criteria:
- non-English speaking
- living greater than 50 miles from medical center
- a disability or illness that would preclude engagement in moderate activity
- medical condition/medication associated with weight
- enrolled in another weight management program
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419951
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: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01419951 History of Changes |
| Other Study ID Numbers: | 2008-0666, K24DK059492 |
| Study First Received: | August 5, 2011 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
Behavioral treatment Preschool aged children Obesity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013