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Treatment of Early Childhood Overweight in Primary Care: Pilot Study

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ClinicalTrials.gov Identifier: NCT01662557
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : August 15, 2012
Sponsor:
Collaborators:
Geisinger Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE August 7, 2012
First Posted Date  ICMJE August 10, 2012
Last Update Posted Date August 15, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2012)
  • Child's Overweight Percentage [ Time Frame: 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) [ Time Frame: Baseline and Month 5 ]
    Change in BMI-z score will be measured from baseline to end of treatment (month 5)
  • Waist Circumference [ Time Frame: 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) [ Time Frame: Baseline and Month 5 ]
    Change in BMI will be measured from baseline to end of treatment (month 5).
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
  • Child's Overweight Percentage [ Time Frame: Baseline and Month 5 ]
    Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)
  • BMI-z [ Time Frame: Baseline and Month 5 ]
    Change in BMI-z score will be measured from baseline to end of treatment (month 5)
  • Waist Circumference [ Time Frame: Baseline and Month 5 ]
    Change in child's waist circumference will be measured from baseline to end of treatment (month 5).
  • BMI [ Time Frame: Baseline and Month 5 ]
    Change in BMI will be measured from baseline to end of treatment (month 5).
Change History Complete list of historical versions of study NCT01662557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
  • Dietary Intake [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Baseline and Month 5 ]
    Change in fasting insulin will be measured at baseline and end of treatment (month 5).
  • Glucose (mg/dl) [ Time Frame: Baseline and Month 5 ]
    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 ]
    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 ]
    Change in HDL levels will be measured from baseline to end of treatment (month 5).
  • LDL (mg/dl) [ Time Frame: Baseline and Month 5 ]
    Change in LDL levels will be measured from baseline to end of treatment (month 5).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Early Childhood Overweight in Primary Care: Pilot Study
Official Title  ICMJE Treatment of Early Childhood Overweight in Primary Care: Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Family Behavior Modification
  • Minimal Nutrition Information
    Weekly mailings emphasizing healthy eating guidelines for families.
    Intervention: Other: Minimal Nutrition Information
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2012)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01662557
Other Study ID Numbers  ICMJE 807610
R34DK080473 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Geisinger Center for Health Research
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Myles S Faith, Ph.D. University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP