Regulating Efficacy and Wellness in Diabetes

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Type 2, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Walking exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking exercise<br>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<br> <br> |
| Active Comparator: Metabolic health education<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | 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 | We will assess changes in self-efficacy by written questionnaires. | Month 6 | 
| Executive function | 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 | We will assess changes in self-regulatory strategy use by written questionnaires. | Month 6 | 
| Physical function | We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months. | Month 6 | 
| Psychosocial outcomes | We will assess changes in psychosocial function ( e.g. self-esteem; social support; anxiety) by written questionnaires. | Month 6 |