- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01790724
Regulating Efficacy and Wellness in Diabetes (REWinD)
February 21, 2017 updated by: Edward McAuley, University of Illinois at Urbana-Champaign
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Walking exercise
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.
|
|
Active Comparator: Metabolic health education
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity
Time Frame: Month 6
|
Change from baseline to month six in physical activity.
Participants will wear an accelerometer to measure physical activity.
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy
Time Frame: Month 6
|
We will assess changes in self-efficacy by written questionnaires.
|
Month 6
|
Executive function
Time Frame: Month 6
|
Participants will complete a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.
|
Month 6
|
Self-regulatory strategy use
Time Frame: Month 6
|
We will assess changes in self-regulatory strategy use by written questionnaires.
|
Month 6
|
Physical function
Time Frame: Month 6
|
We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
|
Month 6
|
Psychosocial outcomes
Time Frame: Month 6
|
We will assess changes in psychosocial function ( e.g.
self-esteem; social support; anxiety) by written questionnaires.
|
Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
February 11, 2013
First Submitted That Met QC Criteria
February 11, 2013
First Posted (Estimate)
February 13, 2013
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13146
- 1F31AG042232-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metabolic Syndrome
-
Universidad de los Andes, ChileCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
Mayo ClinicCompleted
-
Taipei Medical University WanFang HospitalUnknownMetabolic Cardiovascular SyndromeTaiwan
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
Charite University, Berlin, GermanyRecruitingMetabolic Syndrome, Protection AgainstGermany
-
Wageningen University and ResearchPhilips Healthcare; TNO; Friesland Campina; Albert Heijn; Menzis; Smart with food; Vi... and other collaboratorsCompletedMetabolic Syndrome, Protection AgainstNetherlands
-
University of HohenheimGerman Federal Ministry of Education and ResearchCompleted
-
Cairo UniversityCompletedMetabolic Syndrome in WomenEgypt
-
Andalas UniversityHasanuddin University; Universitas Sumatera UtaraCompletedMetabolic Syndrome, Protection AgainstIndonesia
Clinical Trials on Walking exercise
-
South Dakota State UniversityCompletedObesity | Sarcopenia | Metabolic Syndrome X
-
Kaohsiung Veterans General Hospital.Completed
-
National Defense Medical Center, TaiwanMinistry of Science and Technology, TaiwanRecruitingCardiology | PsychiatryTaiwan
-
University of Illinois at ChicagoNational Institute of Nursing Research (NINR)CompletedPeripheral Arterial DiseaseUnited States
-
University of FloridaRecruitingBreast Cancer | Fatigue | Cancer, Therapy-RelatedUnited States
-
Qassim UniversityRecruitingKnee OsteoarthritisSaudi Arabia
-
Beijing Sport UniversityRecruitingHypertension | Cognitive FunctionChina
-
Chulalongkorn UniversityCompleted
-
The University of Hong KongCompletedMajor Depressive Disorder (MDD)Hong Kong
-
University of SaskatchewanCanadian Institutes of Health Research (CIHR)Recruiting