Lifestyle Intervention for Adults With Diabetes

NCT02699307 | Completed

• 1 other identifier: F039731
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

physical activity

Outcome Measures

Primary Outcomes (2)

• Change in physical activity: accelerometer counts

  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.

  baseline, 18 weeks

• Change in physical activity: Community Healthy Activities Model Program for Seniors (CHAMPS) survey

  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.

  baseline, 18 weeks

Secondary Outcomes (1)

• Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center

  baseline, 18 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

OT-led counseling based on home activity pattern

Behavioral: Counseling

Interventions

Counseling BEHAVIORAL

OT led counseling

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pearl G. Lee, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: March 4, 2016
• Study Start: June 1, 2016
• Primary Completion: June 4, 2017
• Study Completion: June 4, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)