The Impact of Educational Materials on Family Behavior | NCT00993434

Studies
The Impact of Educational Materials on Family Behavior

NCT00993434

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 2, 2015Estimated

Enrollment

95Actual

Phase

Not Applicable

Conditions

Overweight
Obesity

Interventions

Booklet on nutrition and physical activity.
Safety Booklet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Oct 8, 2009

First Submission Date that Met QC Criteria

Oct 9, 2009

First Posted Date

Oct 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2015

Last Update Posted Date

Oct 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kid STRIDE Booklet	Active Comparator		Behavioral: Booklet on nutrition and physical activity.
Safety Booklet	Placebo Comparator		Behavioral: Safety Booklet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Booklet on nutrition and physical activity.	Behavioral	Parents will be asked to read the booklet and complete a pre- and post-questionnaire.	Kid STRIDE Booklet

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen R Wald, MD	University of Wisconsin Madison Dept of Pediatrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GHC Capitol Pediatric Clinic		Madison	Wisconsin	53703	United States
UW Health East Towne Pediatrics

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided