Diabetes Mellitus, Type 2NCT02699307
Lifestyle Intervention for Adults With Diabetes
A study testing Counseling in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 4 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Counseling
- Keywords
- physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
OT led counseling
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | OT-led counseling based on home activity pattern Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 18 weeks
Secondary outcomes (1)
Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center
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.
Measured: baseline, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startJun 2016
- Primary completion4 Jun 2017
- Study completion4 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pearl G Lee, MD, University of Michigan
- Investigators
- Pearl G. Lee, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699307
- Sponsor's protocol ID
- F039731
- Status last verified
- Jul 2017
- First submitted
- 10 Feb 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention for Adults With Diabetes
- ClinicalTrials.gov ID
- NCT02699307
- Acronym / sponsor ID
- F039731
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 4 Jun 2017 (actual)
- Study completion
- 4 Jun 2017 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CounselingOT-led counseling based on home activity pattern |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- Medically unstable
- Dementia diagnosis
- Currently taking any medications for memory impairment
- Currently participating in a physical activity program
- Heart attack within the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingOT led counseling | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center
Time frame: baseline, 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pearl G. Lee, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity: accelerometer counts (time frame: baseline, 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.