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Regulating Efficacy and Wellness in Diabetes (REWinD)

Primary Purpose

Diabetes Type 2, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking exercise
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walking exercise

Metabolic health education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Physical Activity
Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.

Secondary Outcome Measures

Self-efficacy
We will assess changes in self-efficacy by written questionnaires.
Executive function
Participants will complete a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.
Self-regulatory strategy use
We will assess changes in self-regulatory strategy use by written questionnaires.
Physical function
We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
Psychosocial outcomes
We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires.

Full Information

First Posted
February 11, 2013
Last Updated
February 21, 2017
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01790724
Brief Title
Regulating Efficacy and Wellness in Diabetes
Acronym
REWinD
Official Title
Social Cognitive and Neuropsychological Influences on Physical Activity Behavior in Type II Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Metabolic health education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Primary Outcome Measure Information:
Title
Physical Activity
Description
Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Self-efficacy
Description
We will assess changes in self-efficacy by written questionnaires.
Time Frame
Month 6
Title
Executive function
Description
Participants will complete a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.
Time Frame
Month 6
Title
Self-regulatory strategy use
Description
We will assess changes in self-regulatory strategy use by written questionnaires.
Time Frame
Month 6
Title
Physical function
Description
We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
Time Frame
Month 6
Title
Psychosocial outcomes
Description
We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward McAuley, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27844326
Citation
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.
Results Reference
derived
Links:
URL
http://www.epl.illinois.edu
Description
Exercise Psychology Lab at University of Illinois at Urbana-Champaign

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Regulating Efficacy and Wellness in Diabetes

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