A Primary Care Educational Intervention for Families of Overweight Children
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational booklet
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight
Eligibility Criteria
Inclusion Criteria:
- Body mass index greater than or equal to the 95th percentile for age and gender
- Presenting to pediatrician for a health maintenance visit
Exclusion Criteria:
- Genetic conditions known to predispose to overweight
- Endocrine conditions associated with overweight
- Chronic steroid therapy
- Current enrollment in a professional weight management program
Sites / Locations
- UW East Towne Pediatric Clinic
- Associated Physicians Pediatric Clinic
- Boys & Girls Club of Dane County
- UW West Pediatric Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Describe parents' perceptions of the educational booklet
Determine the uptake rate of an educational booklet for parents of overweight children between the ages of 7 and 12
Assess the impact of the intervention on BMI as measured by change in BMI z-score
Secondary Outcome Measures
Full Information
NCT ID
NCT00397865
First Posted
November 8, 2006
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00397865
Brief Title
A Primary Care Educational Intervention for Families of Overweight Children
Official Title
A Primary Care Educational Intervention for Families of Overweight Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the research is to find out if an educational booklet is helpful to families with overweight children. The educational booklet contains information for parents about nutritious eating, physical activity, and strategies for healthy living.
Detailed Description
The prevalence of overweight among children has at least doubled in the past 25 years. In the year 2004, 18.8% of children ages 6-11 were overweight. Being overweight as a child is clearly associated with adulthood obesity. In addition, complications once prevalent only in adults are now being seen in overweight children and adolescents. These include hypertension, hypercholesterolemia, and type II diabetes which are well known risk factors for cardiovascular disease. Obesity is also associated with low self-esteem among some groups of overweight adolescents.
Primary care providers are in a unique position to combat this epidemic. However, a recent survey found that only 12% of pediatricians felt highly effective in their ability to treat obesity. Furthermore, physicians reported that low self-efficacy in treating obesity was associated with a lack of patient educational materials. Few written resources for families of overweight children have been tested in the primary care setting. Much of the research on childhood overweight has been conducted in specialty obesity clinics where the resources and patient population may differ from those of primary care offices.
Kid STRIDE is an educational booklet designed for parents of overweight children. It includes information about nutrition, physical activity, and strategies for healthy living. It is hypothesized that the booklet will be distributed to and used by parents of children who are overweight or at risk for overweight. This study will analyze parents' perceptions of this booklet in order to improve its potential value. Information obtained from this pilot study will be used to prepare for a future study to determine the effectiveness of this intervention.
The purpose of this study is:
Aim 1 is to determine the distribution rate and uptake rate of an educational booklet for parents of children between the ages of 8 and 12 who are overweight.
Aim 2 is to describe parents' perceptions of the educational booklet.
Aim 3 is to assess the impact of the intervention on BMI as measured by change in BMI z-score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Educational booklet
Intervention Description
Parental perception of educational booklet and evaluating any change in child's weight.
Primary Outcome Measure Information:
Title
Describe parents' perceptions of the educational booklet
Time Frame
one year
Title
Determine the uptake rate of an educational booklet for parents of overweight children between the ages of 7 and 12
Time Frame
6 months
Title
Assess the impact of the intervention on BMI as measured by change in BMI z-score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index greater than or equal to the 95th percentile for age and gender
Presenting to pediatrician for a health maintenance visit
Exclusion Criteria:
Genetic conditions known to predispose to overweight
Endocrine conditions associated with overweight
Chronic steroid therapy
Current enrollment in a professional weight management program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen R Wald, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW East Towne Pediatric Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
Facility Name
Associated Physicians Pediatric Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Boys & Girls Club of Dane County
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
UW West Pediatric Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15995013
Citation
Whitlock EP, Williams SB, Gold R, Smith PR, Shipman SA. Screening and interventions for childhood overweight: a summary of evidence for the US Preventive Services Task Force. Pediatrics. 2005 Jul;116(1):e125-44. doi: 10.1542/peds.2005-0242.
Results Reference
background
PubMed Identifier
12365956
Citation
Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
Results Reference
background
PubMed Identifier
8147324
Citation
Guo SS, Roche AF, Chumlea WC, Gardner JD, Siervogel RM. The predictive value of childhood body mass index values for overweight at age 35 y. Am J Clin Nutr. 1994 Apr;59(4):810-9. doi: 10.1093/ajcn/59.4.810.
Results Reference
background
PubMed Identifier
10353925
Citation
Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999 Jun;103(6 Pt 1):1175-82. doi: 10.1542/peds.103.6.1175.
Results Reference
background
PubMed Identifier
10617752
Citation
Strauss RS. Childhood obesity and self-esteem. Pediatrics. 2000 Jan;105(1):e15. doi: 10.1542/peds.105.1.e15.
Results Reference
background
PubMed Identifier
15913408
Citation
Perrin EM, Flower KB, Garrett J, Ammerman AS. Preventing and treating obesity: pediatricians' self-efficacy, barriers, resources, and advocacy. Ambul Pediatr. 2005 May-Jun;5(3):150-6. doi: 10.1367/A04-104R.1.
Results Reference
background
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A Primary Care Educational Intervention for Families of Overweight Children
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