ObesityNCT00921323
The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program
A study testing Goal-setting group in people with Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Goal-setting group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Any medical condition that prevents the child from walking during the 12 week study period.
- Non-English speaking student.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine / Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
- Conditions
- Obesity
- Being tested
- Goal-setting group, Control
- Keywords
- Obesity, Physical activity, pedometers, children
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-setting groupBehavioural
This intervention group will be advised to increase their daily steps by at least 20% gradually over 3 months
ControlBehavioural
The control group will be advised to continue to be physically active and record daily steps
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The control group will be advised to continue to be physically active and record daily steps Receives: 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. Receives: Behavioral: Goal-setting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
BMI will be recorded
Measured: 3 months
Secondary outcomes (2)
Daily step counts
Daily step count will be recorded
Measured: 3 months
Survey questionnaire
Participants will be asked to fill out a survey
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Principal investigator, Vincent Aluquin, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921323
- Sponsor's protocol ID
- IRB Protocol No. 29778
- Status last verified
- Apr 2019
- First submitted
- 15 Jun 2009
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program
- ClinicalTrials.gov ID
- NCT00921323
- Acronym / sponsor ID
- IRB Protocol No. 29778
- Conditions
- Obesity
- Keywords
- Obesity, Physical activity, pedometers, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: ControlThe control group will be advised to continue to be physically active and record daily steps |
| Goal-setting group | Active comparator | Behavioral: Goal-setting groupThis intervention group would be instructed to increase their daily step count by at least 20% above their baseline gradually over 3 months. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Any medical condition that prevents the child from walking during the 12 week study period.
- Non-English speaking student.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-setting groupThis intervention group will be advised to increase their daily steps by at least 20% gradually over 3 months | Behavioural | Goal-setting group |
| ControlThe control group will be advised to continue to be physically active and record daily steps | Behavioural | Control |
Primary outcome
Body mass index
Time frame: 3 months
BMI will be recorded
2 secondary outcomes
Daily step counts
Time frame: 3 months
Survey questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-setting group in people with Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.