Regulating Efficacy and Wellness in Diabetes (REWinD)
This study is currently recruiting participants.
Verified February 2013 by University of Illinois at Urbana-Champaign
Sponsor:
University of Illinois at Urbana-Champaign
Collaborator:
Information provided by (Responsible Party):
Edward McAuley, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01790724
First received: February 11, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Type 2 Metabolic Syndrome |
Behavioral: Walking exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Social Cognitive and Neuropsychological Influences on Physical Activity Behavior in Type II Diabetes |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes
Diabetes Medicines
Diabetes Type 2
Exercise and Physical Fitness
Metabolic Syndrome
U.S. FDA Resources
Further study details as provided by University of Illinois at Urbana-Champaign:
Primary Outcome Measures:
- Physical Activity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.
Secondary Outcome Measures:
- Self-efficacy [ Time Frame: Month 6 ] [ Designated as safety issue: No ]We will assess changes in self-efficacy by written questionnaires.
- Executive function [ Time Frame: Month 6 ] [ Designated as safety issue: No ]Participants will complete a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.
- Self-regulatory strategy use [ Time Frame: Month 6 ] [ Designated as safety issue: No ]We will assess changes in self-regulatory strategy use by written questionnaires.
- Physical function [ Time Frame: Month 6 ] [ Designated as safety issue: No ]We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
- Psychosocial outcomes [ Time Frame: Month 6 ] [ Designated as safety issue: No ]We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: Walking exercise |
|
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.
|
Behavioral: Walking exercise |
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790724
Contacts
| Contact: Erin A Olson, MS | 217-300-5326 | olson29@illinois.edu |
Locations
| United States, Illinois | |
| University of Illinois at Urbana-Champaign | Recruiting |
| Urbana, Illinois, United States, 61801 | |
| Contact: Erin A Olson, MS 217-300-5326 olson29@illinois.edu | |
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
| Principal Investigator: | Edward McAuley, PhD | University of Illinois at Urbana-Champaign |
More Information
Additional Information:
No publications provided
| Responsible Party: | Edward McAuley, Principal Investigator, University of Illinois at Urbana-Champaign |
| ClinicalTrials.gov Identifier: | NCT01790724 History of Changes |
| Other Study ID Numbers: | 13146, 1F31AG042232-01A1 |
| Study First Received: | February 11, 2013 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Syndrome X Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on June 18, 2013