Clinical trial NCT00397865: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Overweight
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2006-11-10
Enrollment: 15
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Describe parents' perceptions of the educational booklet
timeFrame: one year
measure: Determine the uptake rate of an educational booklet for parents of overweight children between the ages of 7 and 12
timeFrame: 6 months
measure: Assess the impact of the intervention on BMI as measured by change in BMI z-score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW East Towne Pediatric Clinic
state: Wisconsin
city: Madison
country: United States
facility: Associated Physicians Pediatric Clinic
state: Wisconsin
city: Madison
country: United States
facility: Boys & Girls Club of Dane County
state: Wisconsin
city: Madison
country: United States
facility: UW West Pediatric Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: Strauss RS. Childhood obesity and self-esteem. Pediatrics. 2000 Jan;105(1):e15. doi: 10.1542/peds.105.1.e15.
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.