Lifestyle Intervention for Adults With Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; OT-led counseling based on home activity pattern	Behavioral: Counseling; OT led counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity: accelerometer counts	Change in physical activity from baseline as measured by having participants wearing an accelerometer on their wrists for one week at home at baseline and then at the end of the study.	baseline, 18 weeks
Change in physical activity: Community Healthy Activities Model Program for Seniors (CHAMPS) survey	Change in self reported physical activities (Kcal/week) from baseline as measured by participants answering CHAMPS survey questions at baseline and at the end of the study.	baseline, 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center	Changes in two subdomains of participation - ability to participate and satisfaction with participation, will be assessed by participants answering surveys at the baseline and then at the end of the study.	baseline, 18 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Pearl G. Lee, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 4, 2017
• Study Completion (Actual): June 4, 2017

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: physical activity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: F039731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO