Treatment of Early Childhood Overweight in Primary Care: Pilot Study
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Behavior Modification
Minimal Nutrition Information
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Pediatric Obesity
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
Sites / Locations
- University of Pennsylvania Center for Weight and Eating Disorders
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Family Behavior Modification
Minimal Nutrition Information
Arm Description
Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.
Weekly mailings emphasizing healthy eating guidelines for families.
Outcomes
Primary Outcome Measures
Child's Overweight Percentage
Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)
Body Mass Index z-score (BMI-z)
Change in BMI-z score will be measured from baseline to end of treatment (month 5)
Waist Circumference
Change in child's waist circumference will be measured from baseline to end of treatment (month 5).
Body Mass Index (BMI)
Change in BMI will be measured from baseline to end of treatment (month 5).
Secondary Outcome Measures
Dietary Intake
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
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)
Change in fasting insulin will be measured at baseline and end of treatment (month 5).
Glucose (mg/dl)
Change in fasting glucose levels will be measured from baseline to end of treatment (month 5).
Triglycerides (mg/dl)
Change in fasting triglyceride levels will be measured from baseline to end of treatment (month 5).
HDL (mg/dl)
Change in HDL levels will be measured from baseline to end of treatment (month 5).
LDL (mg/dl)
Change in LDL levels will be measured from baseline to end of treatment (month 5).
Full Information
NCT ID
NCT01662557
First Posted
August 7, 2012
Last Updated
August 14, 2012
Sponsor
University of Pennsylvania
Collaborators
Geisinger Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01662557
Brief Title
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
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Geisinger Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Pediatric Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family Behavior Modification
Arm Type
Active Comparator
Arm Description
Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.
Arm Title
Minimal Nutrition Information
Arm Type
Other
Arm Description
Weekly mailings emphasizing healthy eating guidelines for families.
Intervention Type
Behavioral
Intervention Name(s)
Family Behavior Modification
Other Intervention Name(s)
FBM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Minimal Nutrition Information
Other Intervention Name(s)
MNI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child's Overweight Percentage
Description
Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)
Time Frame
Baseline and Month 5
Title
Body Mass Index z-score (BMI-z)
Description
Change in BMI-z score will be measured from baseline to end of treatment (month 5)
Time Frame
Baseline and Month 5
Title
Waist Circumference
Description
Change in child's waist circumference will be measured from baseline to end of treatment (month 5).
Time Frame
Baseline and Month 5
Title
Body Mass Index (BMI)
Description
Change in BMI will be measured from baseline to end of treatment (month 5).
Time Frame
Baseline and Month 5
Secondary Outcome Measure Information:
Title
Dietary Intake
Description
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.
Time Frame
Baseline and Month 5
Title
Activity Level
Description
Physical activity (sedentary, light, moderate and moderate to vigorous) will be assessed via accelerometry between baseline and end of treatment (month 5).
Time Frame
Baseline to Month 5
Title
Insulin (uUnits/ml)
Description
Change in fasting insulin will be measured at baseline and end of treatment (month 5).
Time Frame
Baseline and Month 5
Title
Glucose (mg/dl)
Description
Change in fasting glucose levels will be measured from baseline to end of treatment (month 5).
Time Frame
Baseline and Month 5
Title
Triglycerides (mg/dl)
Description
Change in fasting triglyceride levels will be measured from baseline to end of treatment (month 5).
Time Frame
Baseline and Month 5
Title
HDL (mg/dl)
Description
Change in HDL levels will be measured from baseline to end of treatment (month 5).
Time Frame
Baseline and Month 5
Title
LDL (mg/dl)
Description
Change in LDL levels will be measured from baseline to end of treatment (month 5).
Time Frame
Baseline and Month 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myles S Faith, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Center for Weight and Eating Disorders
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Early Childhood Overweight in Primary Care: Pilot Study
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