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Lifestyle Intervention for Adults With Diabetes

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University of Michigan

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: Counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02699307
F039731

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Intervention
Experimental group
Description:
OT-led counseling based on home activity pattern
Treatment:
Behavioral: Counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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