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Lifestyle Intervention for Adults With Diabetes

Lifestyle Intervention for Adults With Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02699307
Enrollment
35
Registered
2016-03-04
Start date
2016-06-30
Completion date
2017-06-04
Last updated
2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

physical activity

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.

Interventions

BEHAVIORALCounseling

OT led counseling

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in physical activity: accelerometer countsbaseline, 18 weeksChange 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.
Change in physical activity: Community Healthy Activities Model Program for Seniors (CHAMPS) surveybaseline, 18 weeksChange 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.

Secondary

MeasureTime frameDescription
Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment centerbaseline, 18 weeksChanges 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026