Lifestyle Intervention for Adults With Diabetes

NCT ID: NCT02699307

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-04

Brief Summary

Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among older adults with diabetes. In addition to physical activity, the investigators will also assess if the intervention will improve social participation.

Detailed Description

To tailor to the needs of older adults, the investigators developed an innovative lifestyle modification intervention that incorporates rehabilitation approaches to improve the participation of physical activities (PA) among sedentary older adults with type 2 diabetes. The intervention is developed based on well-established health behavior theory (i.e., self-regulation) and the conceptual framework from the World Health Organization, with several innovations not previously investigated in this population. The intervention:

1. is tailored based on individual's unique patterns of daily PA performed within his/her environment as opposed to the total amount of PA performed in a day or a recall of activities over some time period;

2. uses an accelerometer-assisted, field-based method to address the individual's unique physical and social environment;

3. is delivered by a trained occupational therapist in brief counseling sessions, which can be easily translated into real clinical settings; and

4. addresses participation, a patient-centered outcome that is associated with quality of life but has received limited attention outside of rehabilitation research.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

OT-led counseling based on home activity pattern

Group Type: EXPERIMENTAL

Counseling

Intervention Type: BEHAVIORAL

OT led counseling

Interventions

Counseling

OT led counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 65 years or older
• Has Type 2 diabetes mellitus
• Sedentary (less than 150 minutes of exercise in week)
• English-speaking
• Community living (i.e., not a nursing home resident)
• Ambulatory with or without cane or walker
• Able to operate accelerometer
• Competent to provide informed consent

Exclusion Criteria

• Medically unstable
• Dementia diagnosis
• Currently taking any medications for memory impairment
• Currently participating in a physical activity program
• Heart attack within the past month
• Self-reported illness or condition that would impair the cooperation with the study team or the ability to complete the study

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Pearl G Lee, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pearl G. Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

F039731

Identifier Type: -

Identifier Source: org_study_id