ObesityPhase 1/2NCT00260117
Long-Term Exercise Maintenance Via Internet Support
A Phase 1/2 study testing Exercise in people with Obesity and Inactivity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Each year, a significant portion of men and women who engage in physical activities such as walking or running reduce their activity and by doing so place themselves at greater risk of obesity, heart disease, and diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Inactivity
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2008
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently walking or running for exercise Prior participation in the National Runners' or Walkers' Health Studies
Who cannot join
- Under 18 years old No internet access
Trial locations and contacts
1 site in 1 country.
United States1 site
Lawrence Berkeley National Laboratory
Berkeley, California, 94720
About this study
Each year, a significant portion of men and women who engage in physical activities such as walking or running reduce their activity and by doing so place themselves at greater risk of obesity, heart disease, and diabetes. Our own prospective epidemiological studies of runners and walkers suggest that during 7.6 years of follow-up over 40% have reduced their mileage by half or more. Research suggests that social support, perceived health benefits, resiliency to interruptions in training, and exercise self-efficacy predict successful maintenance. We have found that runners who successfully maintained or increased their running mileage during this follow-up were more likely to have participated in social events such as marathon, half-marathon, or 10km races.
The purpose of this study is to build upon our current Internet-based survey tools (www.healthsurvey.org) for tracking physical activity and nutrition on full-function activity and diet logs. The existing software allows participants to visualize their accumulated running and walking mileage on a virtual transcontinental route starting in Yorktown, Virginia and ending in Florence, Oregon. To the existing software, we will add the ability to: 1) choose named or anonymous running and walking partners with similar goals and abilities to travel with (or race against) along the transcontinental trail, 2) communicate with partners to provide mutual support, 3) compete as part of virtual running and walking teams created by the user, and 4) be recognized for completing each state on an awards page (optional). Interest in the site will be maintained by providing regular updates on scientific research on running and walking through our proprietary software. The updates will be created from PubMed abstracts that are made more reader friendly by defining all scientific terms in pop-up balloons.
Read the detailed description
Participants are refered to a specially designed website to encourage participation
- Conditions
- Obesity, Inactivity
- Being tested
- Exercise
- Keywords
- Exercise, Physical activity, walking, running
- Medical subject headings
- Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Referal to a website
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported body weight
Measured: through2007
Secondary outcomes (1)
Morbidity
Measured: Through 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJan 2005
- Primary completionMar 2008
- Study completionMar 2008
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Paul T Williams, PhD, Principal investigator, Lawrence Berkeley National Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260117
- Sponsor's protocol ID
- DK66738 (completed)
- Status last verified
- Feb 2010
- First submitted
- 29 Nov 2005
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Exercise Maintenance Via Internet Support
- ClinicalTrials.gov ID
- NCT00260117
- Acronym / sponsor ID
- DK66738 (completed)
- Conditions
- Obesity, Inactivity
- Keywords
- Exercise, Physical activity, walking, running
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jan 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 1 Dec 2005 (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.
Each year, a significant portion of men and women who engage in physical activities such as walking or running reduce their activity and by doing so place themselves at greater risk of obesity, heart disease, and diabetes. Our own prospective epidemiological studies of runners and walkers suggest that during 7.6 years of follow-up over 40% have reduced their mileage by half or more. Research suggests that social support, perceived health benefits, resiliency to interruptions in training, and exercise self-efficacy predict successful maintenance. We have found that runners who successfully maintained or increased their running mileage during this follow-up were more likely to have participated in social events such as marathon, half-marathon, or 10km races.
The purpose of this study is to build upon our current Internet-based survey tools (www.healthsurvey.org) for tracking physical activity and nutrition on full-function activity and diet logs. The existing software allows participants to visualize their accumulated running and walking mileage on a virtual transcontinental route starting in Yorktown, Virginia and ending in Florence, Oregon. To the existing software, we will add the ability to: 1) choose named or anonymous running and walking partners with similar goals and abilities to travel with (or race against) along the transcontinental trail, 2) communicate with partners to provide mutual support, 3) compete as part of virtual running and walking teams created by the user, and 4) be recognized for completing each state on an awards page (optional). Interest in the site will be maintained by providing regular updates on scientific research on running and walking through our proprietary software. The updates will be created from PubMed abstracts that are made more reader friendly by defining all scientific terms in pop-up balloons.
Detailed description
Participants are refered to a specially designed website to encourage participation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently walking or running for exercise Prior participation in the National Runners' or Walkers' Health Studies
Key exclusion criteria (1 listed)
- Under 18 years old No internet access
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 |
|---|---|---|
| ExerciseReferal to a website | Behavioural | – |
Primary outcome
Self-reported body weight
Time frame: through2007
1 secondary outcome
Morbidity
Time frame: Through 2007
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 25 Feb 2010.
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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.
Paul T Williams, PhD principal investigator
Lawrence Berkeley National Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise in people with Obesity and Inactivity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 1 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 25 Feb 2010. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Self-reported body weight (time frame: through2007). 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 25 Feb 2010.