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Regulating Efficacy and Wellness in Diabetes (REWinD)

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ClinicalTrials.gov Identifier: NCT01790724
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Diabetes Type 2 Metabolic Syndrome Behavioral: Walking exercise

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Social Cognitive and Neuropsychological Influences on Physical Activity Behavior in Type II Diabetes
Study Start Date : January 2013
Primary Completion Date : December 2013
Study Completion Date : May 2014


Arms and Interventions

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.
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


Outcome Measures

Primary Outcome Measures :
  1. Physical Activity [ Time Frame: Month 6 ]
    Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.


Secondary Outcome Measures :
  1. Self-efficacy [ Time Frame: Month 6 ]
    We will assess changes in self-efficacy by written questionnaires.

  2. 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.

  3. Self-regulatory strategy use [ Time Frame: Month 6 ]
    We will assess changes in self-regulatory strategy use by written questionnaires.

  4. 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.

  5. Psychosocial outcomes [ Time Frame: Month 6 ]
    We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790724


Locations
United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
National Institute on Aging (NIA)
Investigators
Principal Investigator: Edward McAuley, PhD University of Illinois at Urbana-Champaign
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism