The Impact of Educational Materials on Family Behavior

September 30, 2015 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • UW Health West Towne Pediatrics
      • Madison, Wisconsin, United States, 53703
        • GHC Capitol Pediatric Clinic
      • Madison, Wisconsin, United States, 53704
        • UW Health East Towne Pediatrics
      • Madison, Wisconsin, United States, 53792
        • UW Health Park Street Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Kid STRIDE Booklet
Behavioral: Booklet on nutrition and physical activity.
Parents will be asked to read the booklet and complete a pre- and post-questionnaire.
Placebo Comparator: Safety Booklet
Behavioral: Safety Booklet
Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Ellen R Wald, MD, University of Wisconsin Madison Dept of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (Estimate)

October 12, 2009

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2009-1162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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