Clinical trial NCT02699307: Lifestyle Intervention for Adults With Diabetes
Official title: Lifestyle Intervention for Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: physical activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in physical activity: accelerometer counts
timeFrame: baseline, 18 weeks
measure: Change in physical activity: Community Healthy Activities Model Program for Seniors (CHAMPS) survey
timeFrame: baseline, 18 weeks
Secondary outcomes:
measure: Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center
timeFrame: baseline, 18 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Pearl G. Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: