Regulating Efficacy and Wellness in Diabetes

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Diabetes Type 2
• Interventions: Behavioral: Walking exercise

• Registration Number: NCT01790724
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2013-12
• Study Completion: 2014-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking exercise	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.
Metabolic health education	Walking exercise	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity	Month 6	Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.

Secondary Outcome Measures

Name	Time	Method
Executive function	Month 6	Participants will complete a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six.
Physical function	Month 6	We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
Self-efficacy	Month 6	We will assess changes in self-efficacy by written questionnaires.
Psychosocial outcomes	Month 6	We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires.
Self-regulatory strategy use	Month 6	We will assess changes in self-regulatory strategy use by written questionnaires.

Trial Locations

Locations (1)

University of Illinois at Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States