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Clinical Trials/NCT01662557
NCT01662557
Completed
N/A

Treatment of Early Childhood Overweight in Primary Care: Pilot Study

University of Pennsylvania1 site in 1 country51 target enrollmentFebruary 2008
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Pennsylvania
Enrollment
51
Locations
1
Primary Endpoint
Child's Overweight Percentage
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. The primary care setting provides an attractive option for families wishing to receive treatment, yet little is known about the feasibility, acceptance or efficacy of this intervention setting. The purpose of this study was to test two different primary care treatments that were intended to increase fruit and vegetable intake, increase physical activity, and reduce sedentary activity in children ages 4-8, who are overweight or at risk for becoming overweight. Both treatments involved the child and a parent/caregiver and both were conducted over a four month period. The parent/child dyads were selected from the pool of families who receive their primary care within the Geisinger Medical Center geographic area and who have been identified by their pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for age). One group received weekly mailings which focused on healthy eating, promotion of fruit and vegetable intake and physical activity, and methods to reduce TV viewing time. The second group received a group-based intervention at one of the Geisinger Pediatric Clinic sites using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as treatment satisfaction and acceptance. The investigators hypothesized that children who receive Family Behavior Modification (FBM) in the primary care setting will show greater reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference, and that children receiving FBM will show greater improvements in dietary intake, increased physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
March 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 4-8 year old children
  • overweight or obese (BMI≥85th percentile, based on age and sex)
  • Parent/primary caregiver willing to attend sessions with child

Exclusion Criteria

  • Failure to meet BMI criteria
  • Child with elevated internalizing or externalizing behavioral problems, as assessed through Child Behavior Checklist (CBCL)
  • Elevated parent distress, as measured by Symptom Checklist-90 (SCL-90)
  • Child on medications with any weight-altering effect
  • Inability to participate in moderate physical activity or attend study visits
  • Residing \>1 hour from study site

Outcomes

Primary Outcomes

Child's Overweight Percentage

Time Frame: Baseline and Month 5

Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)

Body Mass Index z-score (BMI-z)

Time Frame: Baseline and Month 5

Change in BMI-z score will be measured from baseline to end of treatment (month 5)

Waist Circumference

Time Frame: Baseline and Month 5

Change in child's waist circumference will be measured from baseline to end of treatment (month 5).

Body Mass Index (BMI)

Time Frame: Baseline and Month 5

Change in BMI will be measured from baseline to end of treatment (month 5).

Secondary Outcomes

  • Dietary Intake(Baseline and Month 5)
  • Activity Level(Baseline to Month 5)
  • Insulin (uUnits/ml)(Baseline and Month 5)
  • Glucose (mg/dl)(Baseline and Month 5)
  • Triglycerides (mg/dl)(Baseline and Month 5)
  • HDL (mg/dl)(Baseline and Month 5)
  • LDL (mg/dl)(Baseline and Month 5)

Study Sites (1)

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