NCT00921323

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

June 15, 2009

Last Update Submit

April 8, 2019

Conditions

Obesity

Keywords

ObesityPhysical activitypedometerschildren

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    BMI will be recorded

    3 months

Secondary Outcomes (2)

  • Daily step counts

    3 months

  • Survey questionnaire

    3 months

Study Arms (2)

Control

PLACEBO COMPARATOR

The control group will be advised to continue to be physically active and record daily steps

Behavioral: Control

Goal-setting group

ACTIVE COMPARATOR

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

Interventions

Goal-setting groupBEHAVIORAL

This intervention group will be advised to increase their daily steps by at least 20% gradually over 3 months

Goal-setting group
ControlBEHAVIORAL

The control group will be advised to continue to be physically active and record daily steps

Control

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Any medical condition that prevents the child from walking during the 12 week study period.
  • Non-English speaking student.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine / Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

US(1)