Lifestyle Intervention for Adults With Diabetes
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|ClinicalTrials.gov Identifier: NCT02699307|
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Counseling||Not Applicable|
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:
- 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;
- uses an accelerometer-assisted, field-based method to address the individual's unique physical and social environment;
- is delivered by a trained occupational therapist in brief counseling sessions, which can be easily translated into real clinical settings; and
- 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 (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lifestyle Intervention for Adults With Diabetes|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||June 4, 2017|
|Actual Study Completion Date :||June 4, 2017|
OT-led counseling based on home activity pattern
OT led counseling
- Change in physical activity: accelerometer counts [ Time Frame: baseline, 18 weeks ]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.
- Change in physical activity: Community Healthy Activities Model Program for Seniors (CHAMPS) survey [ Time Frame: baseline, 18 weeks ]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.
- Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center [ Time Frame: baseline, 18 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699307
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48104|
|Principal Investigator:||Pearl G. Lee, MD||University of Michigan|