Treatment of Early Childhood Overweight in Primary Care: Pilot Study

University of Pennsylvania

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Family Behavior Modification; Other: Minimal Nutrition Information

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01662557

R34DK080473 (U.S. NIH Grant/Contract)

807610

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Family Behavior Modification

Active Comparator group

Description:

Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.

Treatment:

Behavioral: Family Behavior Modification

Minimal Nutrition Information

Other group

Description:

Weekly mailings emphasizing healthy eating guidelines for families.

Treatment:

Other: Minimal Nutrition Information