Type 2 DiabetesPhase 1/2NCT00729040
Enhancing Adherence by Building Online Communities
A Phase 1/2 study testing Stepping Up to Health in people with Type 2 Diabetes and Coronary Artery Disease, run by Robert Wood Johnson Foundation.
Trial summary
The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Coronary Artery Disease, Obesity
- What is being tested?
- Stepping Up to Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2009
- 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
- Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes
- Must be sedentary, defined by less than 150 minutes of self-reported activity per week
- Must be 18 or older
- Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista
- Must be a regular email user (checking weekly)
- Must be able to communicate in English
Who cannot join
- Pregnant
- Cannot walk a block (self-report)
- Not competent to sign consent
- Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist)
- Type 1 diabetes
About this study
Official title: Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.
Read the detailed description
Stepping Up to Health with eCommunities is a study that takes what we already know about motivating sedentary, chronically ill people to walk, and begins to explore what it takes to keep people motivated to exercise over time: the ability to self-monitor behavior with accurate ecological momentary assessments.
We have theorized that peer support, monitoring and competition are ways in which people can stay motivated to meet their walking goals; thus, we have built into this intervention online forums for participants to communicate with each other and garner support, as well as a pilot one-to-many competitive game based on the percent of an individual's goal met.
Our research question is whether online community participation can increase adherence to an Internet-mediated walking program, which consists of an uploading pedometer, and going to a website to receive graphical and textual feedback as to whether participants are meeting gradually increasing walking goals. Three hundred participants will spend four months in this randomized, controlled trial to compare the intervention alone to the intervention plus online community support.
- Conditions
- Type 2 Diabetes, Coronary Artery Disease, Obesity
- Being tested
- Stepping Up to Health
- Keywords
- heart, weight, Overweight, bmi, diabetes, type 2, diabetic, walk, walk*, diab*, obese, exercise, activity, coronary, pedometer
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Obesity, Body Weight, Overweight, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping Up to HealthBehavioural
Internet-mediated walking program with pedometers, goal-setting and tailored messaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Stepping Up to Health only Receives: Behavioral: Stepping Up to Health |
| 2 | Experimental | Stepping up to Health PLUS online message boards to talk with other participants Receives: Behavioral: Stepping Up to Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total steps
Measured: last 30 days of intervention
Secondary outcomes (5)
dropout rate
Measured: Four months
days and hours pedometer worn
Measured: four months
login frequency
Measured: four months
upload frequency
Measured: four months
content of posts (qualitative)
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionJan 2009
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 Type 2 DiabetesStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Caroline R Richardson, MD, Principal investigator, University of Michigan Health System Dept. of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729040
- Sponsor's protocol ID
- 57408
- Status last verified
- Jan 2009
- First submitted
- 1 Aug 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Richardson CR, Buis LR, Janney AW, Goodrich DE, Sen A, Hess ML, Mehari KS, Fortlage LA, Resnick PJ, Zikmund-Fisher BJ, Strecher VJ, Piette JD. An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial. J Med Internet Res. 2010 Dec 17;12(4):e71. doi: 10.2196/jmir.1338.
PubMed 21169160Buis LR, Janney AW, Hess ML, Culver SA, Richardson CR. Barriers encountered during enrollment in an internet-mediated randomized controlled trial. Trials. 2009 Aug 23;10:76. doi: 10.1186/1745-6215-10-76.
PubMed 19698154
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
- ClinicalTrials.gov ID
- NCT00729040
- Acronym / sponsor ID
- 57408
- Conditions
- Type 2 Diabetes, Coronary Artery Disease, Obesity
- Keywords
- heart, weight, Overweight, bmi, diabetes, type 2, diabetic, walk
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Aug 2008 (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 determine whether online peer support will increase adherence to an internet-based pedometer walking program.
Detailed description
Stepping Up to Health with eCommunities is a study that takes what we already know about motivating sedentary, chronically ill people to walk, and begins to explore what it takes to keep people motivated to exercise over time: the ability to self-monitor behavior with accurate ecological momentary assessments.
We have theorized that peer support, monitoring and competition are ways in which people can stay motivated to meet their walking goals; thus, we have built into this intervention online forums for participants to communicate with each other and garner support, as well as a pilot one-to-many competitive game based on the percent of an individual's goal met.
Our research question is whether online community participation can increase adherence to an Internet-mediated walking program, which consists of an uploading pedometer, and going to a website to receive graphical and textual feedback as to whether participants are meeting gradually increasing walking goals. Three hundred participants will spend four months in this randomized, controlled trial to compare the intervention alone to the intervention plus online community support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Stepping Up to HealthStepping Up to Health only |
| 2 | Experimental | Behavioral: Stepping Up to HealthStepping up to Health PLUS online message boards to talk with other participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes
- Must be sedentary, defined by less than 150 minutes of self-reported activity per week
- Must be 18 or older
- Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista
- Must be a regular email user (checking weekly)
Key exclusion criteria (5 listed)
- Pregnant
- Cannot walk a block (self-report)
- Not competent to sign consent
- Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist)
- Type 1 diabetes
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 |
|---|---|---|
| Stepping Up to HealthInternet-mediated walking program with pedometers, goal-setting and tailored messaging | Behavioural | 1, 2 |
Primary outcome
Total steps
Time frame: last 30 days of intervention
5 secondary outcomes
dropout rate
Time frame: Four months
days and hours pedometer worn
Time frame: four months
login frequency
Time frame: four months
upload frequency
Time frame: four months
content of posts (qualitative)
Time frame: four 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 29 Jan 2009.
- Derived from this study: PubMed 21169160Richardson CR, Buis LR, Janney AW, Goodrich DE, Sen A, Hess ML, Mehari KS, Fortlage LA, Resnick PJ, Zikmund-Fisher BJ, Strecher VJ, Piette JD. An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial. J Med Internet Res. 2010 Dec 17;12(4):e71. doi: 10.2196/jmir.1338.
- Derived from this study: PubMed 19698154Buis LR, Janney AW, Hess ML, Culver SA, Richardson CR. Barriers encountered during enrollment in an internet-mediated randomized controlled trial. Trials. 2009 Aug 23;10:76. doi: 10.1186/1745-6215-10-76.
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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.
Caroline R Richardson, MD principal investigator
University of Michigan Health System Dept. of Family Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stepping Up to Health in people with Type 2 Diabetes and Coronary Artery Disease, run by Robert Wood Johnson Foundation.
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 6 inclusion and 5 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 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Total steps (time frame: last 30 days of intervention). 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 NCT00729040, 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 29 Jan 2009.