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Completed

NCT Number: NCT02699307

Lifestyle Intervention for Adults With Diabetes

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

OT led counseling

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2016
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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