A Primary Care Educational Intervention for Families of Overweight Children

Obesity Clinical Trial

Official title:

A Primary Care Educational Intervention for Families of Overweight Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397865
• Other study ID #: M-2006-1259
• Status: Completed
• Phase: N/A
• First received: November 8, 2006
• Last updated: October 1, 2015
• Start date: October 2006
• Est. completion date: August 2007

Study information

• Verified date: July 2010
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Educational booklet
Parental perception of educational booklet and evaluating any change in child's weight.

Locations

Country	Name	City	State
United States	Associated Physicians Pediatric Clinic	Madison	Wisconsin
United States	Boys & Girls Club of Dane County	Madison	Wisconsin
United States	UW East Towne Pediatric Clinic	Madison	Wisconsin
United States	UW West Pediatric Clinic	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

Strauss RS. Childhood obesity and self-esteem. Pediatrics. 2000 Jan;105(1):e15. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe parents' perceptions of the educational booklet		one year	No
Primary	Determine the uptake rate of an educational booklet for parents of overweight children between the ages of 7 and 12		6 months	No
Primary	Assess the impact of the intervention on BMI as measured by change in BMI z-score		6 months	No