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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
Sponsor:
Information provided by (Responsible Party):
Pearl G Lee, MD, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Intervention
OT-led counseling based on home activity pattern
Behavioral: Counseling
OT led counseling




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Pearl G. Lee, MD University of Michigan
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Responsible Party: Pearl G Lee, MD, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02699307    
Other Study ID Numbers: F039731
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pearl G Lee, MD, University of Michigan:
physical activity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases