Lifestyle Intervention for Adults With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Lifestyle Intervention for Adults With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699307
• Other study ID #: F039731
• Status: Completed
• Phase: N/A
• First received: February 10, 2016
• Last updated: July 3, 2017
• Start date: June 2016
• Est. completion date: June 4, 2017

Study information

• Verified date: July 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 4, 2017
• Est. primary completion date: June 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Counseling
OT led counseling

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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