Diabetes Type 2REWinDNCT01790724
Regulating Efficacy and Wellness in Diabetes
A study testing Walking exercise in people with Diabetes Type 2 and Metabolic Syndrome, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The propose of the study is to test the hypothesis that an eight week program consisting of walking exercise and social cognitive theory based group workshops will increase physical activity adherence six months later in older adults with type 2 diabetes or metabolic syndrome. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Metabolic Syndrome
- What is being tested?
- Walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2014
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults between the ages of 50-75 years
- individuals diagnosed with type 2 diabetes or metabolic syndrome (presence of 3 of the 5 criteria)
- physician consent to participate.
Who cannot join
- below age 50 or above age 75 at the beginning of the intervention
- exercising regularly more than twice per week for the last six months
- diagnosis of type 1 diabetes mellitus
- failing the Telephone Interview of Cognitive Status
- inability to communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Social Cognitive and Neuropsychological Influences on Physical Activity Behavior in Type II Diabetes
The propose of the study is to test the hypothesis that an eight week program consisting of walking exercise and social cognitive theory based group workshops will increase physical activity adherence six months later in older adults with type 2 diabetes or metabolic syndrome.
- Conditions
- Diabetes Type 2, Metabolic Syndrome
- Being tested
- Walking exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Walking exercise | Experimental | Participants will be instructed in safe walking exercise. They will participate in an eight week, tapered, on-site program. Participants will also attend group workshops where they will learn self-regulatory skills such as goal-setting, self-monitoring, barrier trouble-shooting, rewarding, and relapse prevention and recovery. Receives: Behavioral: Walking exercise |
| Metabolic health education | Active comparator | Participants will complete an eight-week online metabolic health education course. Topics will include glucose control, insulin, weight management, nutrition, physical activity, eye/kidney/foot health, stress reduction, and doctor-patient communication. Receives: Behavioral: Walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.
Measured: Month 6
Secondary outcomes (5)
Self-efficacy
We will assess changes in self-efficacy by written questionnaires.
Measured: Month 6
Executive function
Participants will complete a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.
Measured: Month 6
Self-regulatory strategy use
We will assess changes in self-regulatory strategy use by written questionnaires.
Measured: Month 6
Physical function
We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
Measured: Month 6
Psychosocial outcomes
We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Edward McAuley, University of Illinois at Urbana-Champaign
- Investigators
- Edward McAuley, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790724
- Sponsor's protocol ID
- 13146
- Other IDs
- 1F31AG042232-01A1
- Acronym
- REWinD
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Olson EA, Mullen SP, Raine LB, Kramer AF, Hillman CH, McAuley E. Integrated Social- and Neurocognitive Model of Physical Activity Behavior in Older Adults with Metabolic Disease. Ann Behav Med. 2017 Apr;51(2):272-281. doi: 10.1007/s12160-016-9850-4.
PubMed 27844326
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognitive and Neuropsychological Influences on Physical Activity Behavior in Type II Diabetes
- ClinicalTrials.gov ID
- NCT01790724
- Acronym / sponsor ID
- REWinD / 13146
- Conditions
- Diabetes Type 2, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Feb 2013 (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 propose of the study is to test the hypothesis that an eight week program consisting of walking exercise and social cognitive theory based group workshops will increase physical activity adherence six months later in older adults with type 2 diabetes or metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking exercise | Experimental | Behavioral: Walking exerciseParticipants will be instructed in safe walking exercise. They will participate in an eight week, tapered, on-site program. Participants will also attend group workshops where they will learn self-regulatory skills such as goal-setting, self-monitoring, barrier trouble-shooting, rewarding, and relapse prevention and recovery. |
| Metabolic health education | Active comparator | Behavioral: Walking exerciseParticipants will complete an eight-week online metabolic health education course. Topics will include glucose control, insulin, weight management, nutrition, physical activity, eye/kidney/foot health, stress reduction, and doctor-patient communication. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults between the ages of 50-75 years
- individuals diagnosed with type 2 diabetes or metabolic syndrome (presence of 3 of the 5 criteria)
- physician consent to participate.
Key exclusion criteria (5 listed)
- below age 50 or above age 75 at the beginning of the intervention
- exercising regularly more than twice per week for the last six months
- diagnosis of type 1 diabetes mellitus
- failing the Telephone Interview of Cognitive Status
- inability to communicate in English
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 |
|---|---|---|
| Walking exercise | Behavioural | Metabolic health education, Walking exercise |
Primary outcome
Physical Activity
Time frame: Month 6
Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.
5 secondary outcomes
Self-efficacy
Time frame: Month 6
Executive function
Time frame: Month 6
Self-regulatory strategy use
Time frame: Month 6
Physical function
Time frame: Month 6
Psychosocial outcomes
Time frame: Month 6
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 23 Feb 2017.
- Derived from this study: PubMed 27844326Olson EA, Mullen SP, Raine LB, Kramer AF, Hillman CH, McAuley E. Integrated Social- and Neurocognitive Model of Physical Activity Behavior in Older Adults with Metabolic Disease. Ann Behav Med. 2017 Apr;51(2):272-281. doi: 10.1007/s12160-016-9850-4.
- Exercise Psychology Lab at University of Illinois at Urbana-ChampaignLink provided by the sponsor.
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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.
Edward McAuley, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercise in people with Diabetes Type 2 and Metabolic Syndrome, run by University of Illinois at Urbana-Champaign 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 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 23 Feb 2017. 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.
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?
Physical Activity (time frame: Month 6). 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 NCT01790724, which also lists 1 linked publication.
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 23 Feb 2017; AzTrials last refreshed its copy on 2 Nov 2026.