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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00241891 |
This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.
Condition | Intervention |
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Cardiovascular Diseases Heart Diseases Obesity |
Behavioral: Diet Behavioral: Physical Activity Behavioral: Bullying prevention |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
Official Title: | Primary Care Obesity Prevention: One or Multiple Targets |
Estimated Enrollment: | 350 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Intervention that will target change in multiple behaviors
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Behavioral: Diet
Dietary intervention
Behavioral: Physical Activity
Physical activity intervention
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2: Active Comparator
Intervention that will target only one behavior (beverage consumption)
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Behavioral: Diet
Dietary intervention
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3
Active control intervention that is unrelated to weight (bullying prevention)
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Behavioral: Bullying prevention
Bullying prevention intervention
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BACKGROUND:
In addition to family, school, and community, primary care is a promising setting for childhood obesity prevention. However, most pediatric primary care providers are not trained to deliver behavior modification interventions and, according to preliminary data, are less likely to address obesity prevention when they perceive insufficient time during well-care visits.
DESIGN NARRATIVE:
This is a controlled study of obesity prevention, with group randomization of two standardized 12-month intervention strategies at the practice level. The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification. The first strategy will target change in multiple behaviors, while the second strategy will target only one behavior (beverage consumption). These two interventions will be compared to an active control intervention that is unrelated to weight (bullying prevention). Six to seven primary care practices will be randomized to each arm with 21 patients per practice, for a total of 17 practices and 350 patients. The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index (BMI) increase (adjusted using z-score) in children age 8 to 12 years who are at risk for overweight (BMI 50th-95th percentile), as compared to a control intervention. The study also hypothesizes that the multiple-behavior intervention, the single-behavior intervention, or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization, with no a priori assumption in differences between the two obesity prevention strategies. Blood pressure, insulin resistance, dyslipidemia, and oral health status will be secondary outcomes. Intermediate behavioral outcomes and process data will be collected.
Ages Eligible for Study: | 8 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The Children's Hospital of Philadelphia ( Nicolas Stettler, Principal Investigator ) |
Study ID Numbers: | 336, R01 HL84056 |
Study First Received: | October 17, 2005 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00241891 |
Health Authority: | United States: Federal Government |
Body Weight Signs and Symptoms Obesity Heart Diseases |
Nutrition Disorders Overweight Overnutrition Weight Gain |
Cardiovascular Diseases |