The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
NCT Number: 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.
Looking for future studies?
Notify Me8 year–12 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Focused on changing beverage choices which may have a significant impact on weight.
Other names: Focused on changing beverage choices with the goal
Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
Focused on standard intervention strategies unrelated to weight including bullying prevention.
Time frame: Measured at Month 12
Children's Hospital of Philadelphia
Other
Primary Care Obesity Prevention: One or Multiple Targets
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00087919
Body Weight, Cardiovascular Diseases
View Trial DetailsNCT00005437
Body Weight, Cardiovascular Diseases
View Trial DetailsNCT00000615
Body Weight, Cardiovascular Diseases
View Trial DetailsNCT00122993
Body Weight, Cardiovascular Diseases
Minneapolis, Minnesota, United States
View Trial Details