- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01662557
Treatment of Early Childhood Overweight in Primary Care: Pilot Study
August 14, 2012 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Center for Weight and Eating Disorders
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
Other: Minimal Nutrition Information
Weekly mailings emphasizing healthy eating guidelines for families.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline and 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)
|
Baseline and 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).
|
Baseline and 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).
|
Baseline and Month 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Month 5
|
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).
|
Baseline to 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).
|
Baseline and 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).
|
Baseline and 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).
|
Baseline and 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).
|
Baseline and 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).
|
Baseline and Month 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Myles S Faith, Ph.D., University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
August 7, 2012
First Submitted That Met QC Criteria
August 9, 2012
First Posted (Estimate)
August 10, 2012
Study Record Updates
Last Update Posted (Estimate)
August 15, 2012
Last Update Submitted That Met QC Criteria
August 14, 2012
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 807610
- R34DK080473 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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