Regulating Efficacy and Wellness in Diabetes

Metabolic Syndrome Clinical Trial

— REWinD  

Official title:

Social Cognitive and Neuropsychological Influences on Physical Activity Behavior in Type II Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790724
• Other study ID #: 13146
• Secondary ID: 1F31AG042232-01A
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: February 21, 2017
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2017
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Walking exercise

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.	Month 6
Secondary	Self-efficacy	We will assess changes in self-efficacy by written questionnaires.	Month 6
Secondary	Executive function	Participants will complete a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.	Month 6
Secondary	Self-regulatory strategy use	We will assess changes in self-regulatory strategy use by written questionnaires.	Month 6
Secondary	Physical function	We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.	Month 6
Secondary	Psychosocial outcomes	We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires.	Month 6

External Links

•   Exercise Psychology Lab at University of Illinois at Urbana-Champaign