Type 2 Diabetes MellitusNCT02268916

Physical Activity and Participation

A study testing Counseling and Usual education in people with Type 2 Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Counseling and Usual education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2015to 31 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Veterans
Aged 60 years or older
Has Type 2 diabetes mellitus
Able to operate accelerometer
Competent to consent to the study
No dementia diagnosis

Show all 10Show fewer

Ambulatory with or without assistive device
English-speaking
Community living (i.e., not a nursing home resident)
Not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week)

Who cannot join

Medically unstable
Hospitalized within the last 6 months
2 or more days of complete bed rest in the last month
hemiplegia or limb amputation
Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study
work involved in shift schedule

Show all 10Show fewer

current enrollment of a physical activity program
replacement of hip or knee within the last 6 months.
Parkinson's disease
frequent falls

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105

Other trials in United States

About this study

Official title: Veterans With Diabetes Mellitus: Improving Physical Activity and Participation

The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.

Read the detailed description

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 Veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.

Conditions: Type 2 Diabetes Mellitus
Being tested: Counseling, Usual education
Keywords: diabetes, physical activity, participation
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, 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
Usual educationBehavioural
At the end of the study, will receive OT-led counseling

Study groups in NCT02268916
Study group	Role	What they receive
Intervention	Experimental	OT-led counseling based on home activity pattern Receives: Behavioral: Counseling
Wait-listed	Placebo comparator	Usual activity during the study. At the end of the study, will receive OT-led counseling Receives: Behavioral: Usual education

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical Activity
Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.
Measured: 6 months
Social Participation
Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201531 Dec 2019

First posted20 Oct 2014 (estimated)
Study start1 Jun 2015
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02268916
Sponsor's protocol ID: O1190-W
Status last verified: Sep 2022
First submitted: 15 Oct 2014
Last updated: 19 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Veterans With Diabetes Mellitus: Improving Physical Activity and Participation
ClinicalTrials.gov ID: NCT02268916
Acronym / sponsor ID: O1190-W
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes, physical activity, participation
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jun 2015 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 20 Oct 2014 (estimated)
Results: Posted 19 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: CounselingOT-led counseling based on home activity pattern
Wait-listed	Placebo comparator	Behavioral: Usual educationUsual activity during the study. At the end of the study, will receive OT-led counseling

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Veterans
Aged 60 years or older
Has Type 2 diabetes mellitus
Able to operate accelerometer
Competent to consent to the study

Key exclusion criteria (10 listed)

Medically unstable
Hospitalized within the last 6 months
2 or more days of complete bed rest in the last month
hemiplegia or limb amputation
Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study

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
Usual educationAt the end of the study, will receive OT-led counseling	Behavioural	Wait-listed

Primary outcome

Physical Activity
Time frame: 6 months
Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.
Social Participation
Time frame: 6 months
Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months.

Results and safety

Results posted to the registry on 19 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	52	35
Wait-listed	52	42

Primary outcome: Physical Activity

Time frame: 6 months. Mean (Standard Deviation). Unit: KCal/week

Measure	Intervention n = 35	Wait-listed n = 42
Value	401.88 (3909.59)	-263.81 (4414.79)

Intervention vs Wait-listed: Mean Difference (Final Values): 0.39 (95% CI -0.18 to 0.97), p =0.18, Mixed Models Analysis

Population analysed: Only participants who completed the home monitoring activities were included in the outcomes analysis.

Primary outcome: Social Participation

Time frame: 6 months. Mean (Standard Deviation). Unit: T-score

Measure	Intervention n = 35	Wait-listed n = 42
Satisfaction social roles	0.18 (7.47)	0.63 (8.43)
Satisfaction discretionary social roles	0.35 (8.14)	0.85 (7.29)
Ability to participate social roles and activities	-0.55 (7.50)	-0.36 (7.40)

Intervention vs Wait-listed: Slope: -2.20 (95% CI -5.45 to 1.06), p = 0.19, Mixed Models Analysis
Intervention vs Wait-listed: Slope: -1.02 (95% CI -4.53 to 2.48), p = 0.57, Mixed Models Analysis
Intervention vs Wait-listed: Slope: -2.44 (95% CI -5.52 to 0.63), p = 0.12, Mixed Models Analysis

Population analysed: Only participants with completed surveys were included in the analysis.

Adverse events

Time frame: For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 52 (0%)	2 of 52 (3.8%)	0 of 52
Wait-listed Without OT-Led Counseling	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Wait-listed With OT-Led Counseling	0 of 52 (0%)	1 of 52 (1.9%)	0 of 52

Limitations and caveats (from the sponsor): The study participants are predominantly male and are all veterans, so the results would be difficult to be generalized to female and non-veterans. Physical activity is measured by a survey, which may have recall bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

VA Ann Arbor Healthcare System, Ann Arbor, MI

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 and Usual education in people with Type 2 Diabetes Mellitus, run by VA Office of Research and Development 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 10 inclusion and 10 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 19 Sep 2022. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Physical Activity (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT02268916.

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 19 Sep 2022; AzTrials last refreshed its copy on 29 Oct 2026.