The Impact of Educational Materials on Family Behavior
This study has been completed.
Sponsor:
University of Wisconsin, Madison
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
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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
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:
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013