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
  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:


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
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: 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 September 18, 2014