Treatment of Early Childhood Overweight in Primary Care: Pilot Study

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Family Behavior Modification; Other: Minimal Nutrition Information

• Registration Number: NCT01662557
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-02
• Status Verified: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-10
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Behavior Modification	Family Behavior Modification	Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.
Minimal Nutrition Information	Minimal Nutrition Information	Weekly mailings emphasizing healthy eating guidelines for families.

Primary Outcome Measures

Name	Time	Method
Child's Overweight Percentage	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)	Baseline and Month 5	Change in BMI-z score will be measured from baseline to end of treatment (month 5)
Waist Circumference	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)	Baseline and Month 5	Change in BMI will be measured from baseline to end of treatment (month 5).

Secondary Outcome Measures

Name	Time	Method
Dietary Intake	Baseline and Month 5	Change in dietary intake (kcals, protein, fat, saturated fat, cholesterol, fiber, carbohydrate, fruit/veg servings, Vitamins A and C) will be assessed from baseline to end of treatment (month 5) using 24-hour recall interviews.
Activity Level	Baseline to Month 5	Physical activity (sedentary, light, moderate and moderate to vigorous) will be assessed via accelerometry between baseline and end of treatment (month 5).
Insulin (uUnits/ml)	Baseline and Month 5	Change in fasting insulin will be measured at baseline and end of treatment (month 5).
Glucose (mg/dl)	Baseline and Month 5	Change in fasting glucose levels will be measured from baseline to end of treatment (month 5).
Triglycerides (mg/dl)	Baseline and Month 5	Change in fasting triglyceride levels will be measured from baseline to end of treatment (month 5).
HDL (mg/dl)	Baseline and Month 5	Change in HDL levels will be measured from baseline to end of treatment (month 5).
LDL (mg/dl)	Baseline and Month 5	Change in LDL levels will be measured from baseline to end of treatment (month 5).

Trial Locations

Locations (1)

University of Pennsylvania Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States