Physical InactivityEarly Phase 1STEPSNCT01264757
Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
A Early Phase 1 study testing Physical Activity Educational Materials and Pedometer in people with Physical Inactivity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This feasibility study specifically addresses the issue of adapting US dietary guidelines physical activity recommendations to the population of the Lower Mississippi Delta. The hypothesis is that including a pedometer as a self-monitoring tool as part of adapted physical activity guidelines will result in greater… Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Physical Activity Educational Materials and Pedometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2010
- Phase
- Early Phase 1
- 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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 35 to 64 years of age
- body mass index (BMI) between 25 and 34.9 kg/m2
- being able to walk without limitation
Who cannot join
- cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric problems; musculoskeletal problems interfering with exercise
- immunodeficiency problems
- malignancies in the last 5 years
- any other medical condition or life threatening disease that could be aggravated by exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
This feasibility study specifically addresses the issue of adapting US dietary guidelines physical activity recommendations to the population of the Lower Mississippi Delta. The hypothesis is that including a pedometer as a self-monitoring tool as part of adapted physical activity guidelines will result in greater immediate increases in physical activity (as monitored by an accelerometer) than an education program alone.
Read the detailed description
The purpose of this study was to determine if a short-term pedometer-based intervention results in immediate increases in time spent in moderate-to-vigorous physical activity (MVPA) compared to a minimal educational intervention.A sample of 43 overweight adults 35 to 64 years of age participated in a one week pedometer-based feasibility trial monitored by accelerometry. Participants were randomized into a one-week education-only group or a group that also wore a pedometer. Accelerometer-measured MVPA was measured over 7 days at baseline and post-intervention.
- Conditions
- Physical Inactivity
- Being tested
- Physical Activity Educational Materials, Pedometer
- Keywords
- pedometer, accelerometer, moderate-to-vigorous physical activity, adult, randomized trial
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Educational MaterialsBehavioural
A brochure was provided to participants about the health benefits of physical activity and physical activity recommendations
PedometerBehavioural
A pedometer was provided to participants in addition to educational materials about the health benefits of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Education | Active comparator | Educational brochure about physical activity provided. Receives: Behavioral: Physical Activity Educational Materials |
| Pedometer | Experimental | A pedometer was provided in addition to educational materials. Receives: Behavioral: Pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes spent in moderate-to-vigorous physical activity (MVPA)
A GT3X accelerometer is used to monitor each participants physical activity levels for seven consecutive days at baseline and again following a 7-day intervention period. The amount of time per day spent above a threshold of 2200 accelerometer counts/min is averaged over at least three days as the measure of MVPA.
Measured: The primary outcome is measured at baseline and after a 7-day intervention period (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Peter T. Katzmarzyk, Pennington Biomedical Research Center
- Investigators
- Peter T Katzmarzyk, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264757
- Sponsor's protocol ID
- PBRC 29034
- Acronym
- STEPS
- Status last verified
- Feb 2016
- First submitted
- 3 Dec 2010
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Katzmarzyk PT, Champagne CM, Tudor-Locke C, Broyles ST, Harsha D, Kennedy BM, Johnson WD. A short-term physical activity randomized trial in the Lower Mississippi Delta. PLoS One. 2011;6(10):e26667. doi: 10.1371/journal.pone.0026667. Epub 2011 Oct 25.
PubMed 22046325Harrington DM, Tudor-Locke C, Champagne CM, Broyles ST, Harsha DW, Kennedy BM, Johnson WD, Allen R, Katzmarzyk PT. Step-based translation of physical activity guidelines in the Lower Mississippi Delta. Appl Physiol Nutr Metab. 2011 Aug;36(4):583-5. doi: 10.1139/h11-053. Epub 2011 Aug 19.
PubMed 21854159
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
- ClinicalTrials.gov ID
- NCT01264757
- Acronym / sponsor ID
- STEPS / PBRC 29034
- Conditions
- Physical Inactivity
- Keywords
- pedometer, accelerometer, moderate-to-vigorous physical activity, adult, randomized trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Feb 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Dec 2010 (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.
This feasibility study specifically addresses the issue of adapting US dietary guidelines physical activity recommendations to the population of the Lower Mississippi Delta. The hypothesis is that including a pedometer as a self-monitoring tool as part of adapted physical activity guidelines will result in greater immediate increases in physical activity (as monitored by an accelerometer) than an education program alone.
Detailed description
The purpose of this study was to determine if a short-term pedometer-based intervention results in immediate increases in time spent in moderate-to-vigorous physical activity (MVPA) compared to a minimal educational intervention.A sample of 43 overweight adults 35 to 64 years of age participated in a one week pedometer-based feasibility trial monitored by accelerometry. Participants were randomized into a one-week education-only group or a group that also wore a pedometer. Accelerometer-measured MVPA was measured over 7 days at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Active comparator | Behavioral: Physical Activity Educational MaterialsEducational brochure about physical activity provided. |
| Pedometer | Experimental | Behavioral: PedometerA pedometer was provided in addition to educational materials. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 35 to 64 years of age
- body mass index (BMI) between 25 and 34.9 kg/m2
- being able to walk without limitation
Key exclusion criteria (4 listed)
- cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric problems; musculoskeletal problems interfering with exercise
- immunodeficiency problems
- malignancies in the last 5 years
- any other medical condition or life threatening disease that could be aggravated by exercise
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 |
|---|---|---|
| Physical Activity Educational MaterialsA brochure was provided to participants about the health benefits of physical activity and physical activity recommendations | Behavioural | Education |
| PedometerA pedometer was provided to participants in addition to educational materials about the health benefits of physical activity. | Behavioural | Pedometer |
Primary outcome
Minutes spent in moderate-to-vigorous physical activity (MVPA)
Time frame: The primary outcome is measured at baseline and after a 7-day intervention period (1 week)
A GT3X accelerometer is used to monitor each participants physical activity levels for seven consecutive days at baseline and again following a 7-day intervention period. The amount of time per day spent above a threshold of 2200 accelerometer counts/min is averaged over at least three days as the measure of MVPA.
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 5 Feb 2016.
- Background: PubMed 22046325Katzmarzyk PT, Champagne CM, Tudor-Locke C, Broyles ST, Harsha D, Kennedy BM, Johnson WD. A short-term physical activity randomized trial in the Lower Mississippi Delta. PLoS One. 2011;6(10):e26667. doi: 10.1371/journal.pone.0026667. Epub 2011 Oct 25.
- Results publication: PubMed 21854159Harrington DM, Tudor-Locke C, Champagne CM, Broyles ST, Harsha DW, Kennedy BM, Johnson WD, Allen R, Katzmarzyk PT. Step-based translation of physical activity guidelines in the Lower Mississippi Delta. Appl Physiol Nutr Metab. 2011 Aug;36(4):583-5. doi: 10.1139/h11-053. Epub 2011 Aug 19.
- Individual participant dataSharing planned: No
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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.
Peter T Katzmarzyk, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Physical Activity Educational Materials and Pedometer in people with Physical Inactivity, run by Pennington Biomedical Research 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 3 inclusion and 4 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 5 Feb 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Minutes spent in moderate-to-vigorous physical activity (MVPA) (time frame: The primary outcome is measured at baseline and after a 7-day intervention period (1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01264757, which also lists 2 linked publications.
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 5 Feb 2016.