Clinical trial NCT01662557: Treatment of Early Childhood Overweight in Primary Care: Pilot Study
Official title: Treatment of Early Childhood Overweight in Primary Care: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Pediatric Obesity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Geisinger Center for Health Research
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-08-10
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Child's Overweight Percentage
timeFrame: Baseline and Month 5
measure: Body Mass Index z-score (BMI-z)
timeFrame: Baseline and Month 5
measure: Waist Circumference
timeFrame: Baseline and Month 5
measure: Body Mass Index (BMI)
timeFrame: Baseline and Month 5
Secondary outcomes:
measure: Dietary Intake
timeFrame: Baseline and Month 5
measure: Activity Level
timeFrame: Baseline to Month 5
measure: Insulin (uUnits/ml)
timeFrame: Baseline and Month 5
measure: Glucose (mg/dl)
timeFrame: Baseline and Month 5
measure: Triglycerides (mg/dl)
timeFrame: Baseline and Month 5
measure: HDL (mg/dl)
timeFrame: Baseline and Month 5
measure: LDL (mg/dl)
timeFrame: Baseline and Month 5
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Myles S Faith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: