Back to resultsThe Impact of Educational Materials on Family Behavior
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Booklet on nutrition and physical activity.
Safety Booklet
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Child
Eligibility Criteria
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.
Sites / Locations
- GHC Capitol Pediatric Clinic
- UW Health East Towne Pediatrics
- UW Health West Towne Pediatrics
- UW Health Park Street Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Kid STRIDE Booklet
Safety Booklet
Arm Description
Outcomes
Primary Outcome Measures
Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.
Secondary Outcome Measures
Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.
Full Information
NCT ID
NCT00993434
First Posted
October 8, 2009
Last Updated
September 30, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00993434
Brief Title
The Impact of Educational Materials on Family Behavior
Official Title
The Impact of Educational Materials on Family Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (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 learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kid STRIDE Booklet
Arm Type
Active Comparator
Arm Title
Safety Booklet
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Booklet on nutrition and physical activity.
Intervention Description
Parents will be asked to read the booklet and complete a pre- and post-questionnaire.
Intervention Type
Behavioral
Intervention Name(s)
Safety Booklet
Intervention Description
Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.
Primary Outcome Measure Information:
Title
Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen R Wald, MD
Organizational Affiliation
University of Wisconsin Madison Dept of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHC Capitol Pediatric Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53703
Country
United States
Facility Name
UW Health East Towne Pediatrics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
Facility Name
UW Health West Towne Pediatrics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
UW Health Park Street Pediatrics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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The Impact of Educational Materials on Family Behavior
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