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The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program

This study has been completed.
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
Vincent P.R. Aluquin, Penn State University
ClinicalTrials.gov Identifier:
NCT00921323
First received: June 15, 2009
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is:

  • To validate the use of pedometers in assessing the level of physical activity in middle school children.
  • To evaluate whether setting a step goal through the use of pedometers could increase physical activity and prevent weight gain in middle school children.

Condition Intervention
Obesity
 Behavioral: Goal-setting group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Body mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily step counts [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Survey questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
The control group will be advised to continue to be physically active and record daily steps
Active Comparator: Goal-setting group
This intervention group would be instructed to increase their daily step count by at least 20% above their baseline gradually over 3 months.
 Behavioral: Goal-setting group
This intervention group will be advised to increase their daily steps by at least 20% gradually over 3 months

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All healthy 8th grade students at the Springboard Academy of the Milton Hershey School willing to participate in the study and whose parents give consent.

Exclusion Criteria:

  • Any medical condition that prevents the child from walking during the 12 week study period.
  • Non-English speaking student.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921323

Locations
United States, Pennsylvania
Penn State College of Medicine / Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Children's Miracle Network
  More Information

No publications provided

Responsible Party: Vincent P.R. Aluquin, Assistant Professor of Pediatrics, Penn State University
ClinicalTrials.gov Identifier: NCT00921323     History of Changes
Other Study ID Numbers: IRB Protocol No. 29778
Study First Received: June 15, 2009
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Obesity
Physical activity
pedometers
children

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013