NCT00993434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 2, 2015

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

October 8, 2009

Last Update Submit

September 30, 2015

Conditions

Keywords

Child

Outcome Measures

Primary Outcomes (1)

  • Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.

    3 months

Secondary Outcomes (1)

  • Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.

    3 months

Study Arms (2)

Kid STRIDE Booklet

ACTIVE COMPARATOR
Behavioral: Booklet on nutrition and physical activity.

Safety Booklet

PLACEBO COMPARATOR
Behavioral: Safety Booklet

Interventions

Parents will be asked to read the booklet and complete a pre- and post-questionnaire.

Kid STRIDE Booklet
Safety BookletBEHAVIORAL

Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.

Safety Booklet

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with a BMI greater than or equal to 85% along with a parent.
  • All subjects must speak English.

You may not qualify if:

  • Genetic conditions associated with overweight.
  • Endocrine conditions associated with overweight.
  • Chronic steroid therapy.
  • Current enrollment in a professional weight management program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GHC Capitol Pediatric Clinic

Madison, Wisconsin, 53703, United States

Location

UW Health East Towne Pediatrics

Madison, Wisconsin, 53704, United States

Location

UW Health West Towne Pediatrics

Madison, Wisconsin, 53717, United States

Location

UW Health Park Street Pediatrics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ellen R Wald, MD

    University of Wisconsin Madison Dept of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 12, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 2, 2015

Record last verified: 2012-11

Locations