Treatment of Early Childhood Overweight in Primary Care: Pilot Study

NCT01662557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2012-08-15

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Family Behavior Modification

5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions.

OTHER

Minimal Nutrition Information

Families assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals.

Sponsors & Collaborators

  • Geisinger Center for Health Research

    collaborator UNKNOWN
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Myles S Faith, Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662557 on ClinicalTrials.gov