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

  • United States
    • 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.
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

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.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

National Institute on Aging (NIA)

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.

General Publications

Helpful Links

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.

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