The Impact of Educational Materials on Family Behavior

Obesity Clinical Trial

Official title:

The Impact of Educational Materials on Family Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993434
• Other study ID #: M-2009-1162
• Status: Completed
• Phase: N/A
• First received: October 8, 2009
• Last updated: September 30, 2015
• Start date: October 2009
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• 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 learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.

Description:

Few written resources for families have been tested in the primary care setting. Kid STRIDE (STRiving to Improve Diet & Exercise) is an educational booklet designed for parents of overweight children. We hypothesize that this booklet will benefit a small percentage of the overweight and obese population of children as a first-tiered approach to treatment of overweight and obese children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children with a BMI greater than or equal to 85% along with a parent.

• All subjects must speak English.

Exclusion Criteria:

• Genetic conditions associated with overweight.

• Endocrine conditions associated with overweight.

• Chronic steroid therapy.

• Current enrollment in a professional weight management program.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Booklet on nutrition and physical activity.
Parents will be asked to read the booklet and complete a pre- and post-questionnaire.
• Safety Booklet
Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.

Locations

Country	Name	City	State
United States	GHC Capitol Pediatric Clinic	Madison	Wisconsin
United States	UW Health East Towne Pediatrics	Madison	Wisconsin
United States	UW Health Park Street Pediatrics	Madison	Wisconsin
United States	UW Health West Towne Pediatrics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.		3 months	No
Secondary	Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.		3 months	No