Treatment of Early Childhood Overweight in Primary Care: Pilot Study

This study has been completed.
Sponsor:
Collaborators:
Geisinger Center for Health Research
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01662557
First received: August 7, 2012
Last updated: August 14, 2012
Last verified: January 2011
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Family Behavior Modification
Other: Minimal Nutrition Information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Early Childhood Overweight in Primary Care: Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Child's Overweight Percentage [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in BMI-z score will be measured from baseline to end of treatment (month 5)

  • Waist Circumference [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in BMI will be measured from baseline to end of treatment (month 5).


Secondary Outcome Measures:
  • Dietary Intake [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 5 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    Change in fasting insulin will be measured at baseline and end of treatment (month 5).

  • Glucose (mg/dl) [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    Change in fasting glucose levels will be measured from baseline to end of treatment (month 5).

  • Triglycerides (mg/dl) [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    Change in fasting triglyceride levels will be measured from baseline to end of treatment (month 5).

  • HDL (mg/dl) [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    Change in HDL levels will be measured from baseline to end of treatment (month 5).

  • LDL (mg/dl) [ Time Frame: Baseline and Month 5 ] [ Designated as safety issue: No ]
    Change in LDL levels will be measured from baseline to end of treatment (month 5).


Enrollment: 51
Study Start Date: February 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Family Behavior Modification
Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.
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 Name: FBM
Minimal Nutrition Information
Weekly mailings emphasizing healthy eating guidelines for families.
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.
Other Name: MNI

  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662557

Locations
United States, Pennsylvania
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Geisinger Center for Health Research
Investigators
Principal Investigator: Myles S Faith, Ph.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01662557     History of Changes
Other Study ID Numbers: 807610, R34DK080473
Study First Received: August 7, 2012
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Pediatric Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014