Regulating Efficacy and Wellness in Diabetes (REWinD)

This study is ongoing, but not recruiting participants.
Sponsor:
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: December 9, 2013
Last verified: December 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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: December 9, 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 July 23, 2014