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Behavioral Intervention
Behavioral Interventions for Childhood Obesity
Nashville, TN
N/A
Recruiting
Led By Amanda Staiano, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI≥95th percentile for age and sex based on standardized CDC growth curves
Parent/caregiver aged ≥ 18 years old
Must not have
Participant child is taking weight management medications at the time of enrollment
Participant child plans to undergo bariatric surgery or another weight loss operation during the 12-month study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 times over 12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the effects of different durations of Intensive Behavioral Therapy (IBT) on 900 obese children aged 5-17 from Tennessee and Louisiana. The children and their caregivers are
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Who is the study for?
This trial is for children aged 5-17 living in Tennessee or Louisiana who are dealing with obesity. The study involves the child and their caregiver, but specific inclusion and exclusion criteria details were not provided.Check my eligibility
What is being tested?
The trial is testing how different amounts of Intensive Behavioral Therapy (IBT) affect childhood obesity. Children are randomly placed into groups to receive either 26, 22, 19, 16, or 13 hours of IBT over six months. Health changes will be tracked through BMI and lifestyle factors like diet and exercise.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medication, traditional side effects are not expected. However, participants may experience changes in mood or behavior due to lifestyle adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is in the top 5% for my age and gender.
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I am a parent or caregiver and I am 18 years old or older.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child is currently on medication for weight management.
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Select...
My child is scheduled for a weight loss surgery within the next 12 months.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 times over 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 times over 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of the 95th BMI Percentile
Secondary study objectives
Child Diet
Child Media Use
Child Sleep
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: 26-hour intensive behavioral lifestyle interventionExperimental Treatment1 Intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session).
Group II: 16-hour intensive behavioral lifestyle interventionActive Control1 Intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 8 sessions (45 minutes per session).
Group III: 22-hour intensive behavioral lifestyle interventionActive Control1 Intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 12 sessions (60 minutes per session).
Group IV: 19-hour intensive behavioral lifestyle interventionActive Control1 Intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professiona for 9 sessions (60 minutes per session).
Group V: 13-hour intensive behavioral lifestyle interventionActive Control1 Intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 6 sessions (30 minutes per session).
Find a Location
Closest Location:Vanderbilt University Medical Center· Nashville, TN· 334 miles
Who is running the clinical trial?
Pennington Biomedical Research CenterOTHER
313 Previous Clinical Trials
182,102 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
919 Previous Clinical Trials
937,846 Total Patients Enrolled
Amanda Staiano, PhDPrincipal InvestigatorPennington Biomedical Research Center
4 Previous Clinical Trials
133 Total Patients Enrolled
William Heerman, MD MPHPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
117 Total Patients Enrolled