The Impact of Educational Materials on Family Behavior

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ellen R Wald, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00993434
First received: October 8, 2009
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Booklet on nutrition and physical activity.
Behavioral: Safety Booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Impact of Educational Materials on Family Behavior

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: October 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993434

Locations
United States, Wisconsin
UW Health Park Street Pediatrics
Madison, Wisconsin, United States, 53792
UW Health West Towne Pediatrics
Madison, Wisconsin, United States, 53717
UW Health East Towne Pediatrics
Madison, Wisconsin, United States, 53704
GHC Capitol Pediatric Clinic
Madison, Wisconsin, United States, 53703
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Ellen R Wald, MD University of Wisconsin Madison Dept of Pediatrics
  More Information

No publications provided

Responsible Party: Ellen R Wald, Chair, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00993434     History of Changes
Other Study ID Numbers: M-2009-1162
Study First Received: October 8, 2009
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Child

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014