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
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Behavioral: Family Behavior Modification Other: Minimal Nutrition Information | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Early Childhood Overweight in Primary Care: Pilot Study |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |
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.
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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.
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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 |
- 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).
- 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).

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Ages Eligible for Study: | 4 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662557
United States, Pennsylvania | |
University of Pennsylvania Center for Weight and Eating Disorders | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Myles S Faith, Ph.D. | University of Pennsylvania |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01662557 History of Changes |
Other Study ID Numbers: |
807610 R34DK080473 ( U.S. NIH Grant/Contract ) |
First Posted: | August 10, 2012 Key Record Dates |
Last Update Posted: | August 15, 2012 |
Last Verified: | January 2011 |
Pediatric Obesity |
Pediatric Obesity Overweight Obesity Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |