Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, physical activity, participation
Brief summary
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
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.
Interventions
BEHAVIORALCounseling
OT led counseling
BEHAVIORALUsual education
At the end of the study, will receive OT-led counseling
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans * Aged 60 years or older * Has Type 2 diabetes mellitus * Able to operate accelerometer * Competent to consent to the study * No dementia diagnosis * 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)
Exclusion criteria
* 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 * current enrollment of a physical activity program * replacement of hip or knee within the last 6 months. * Parkinson's disease * frequent falls
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | 6 months | Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention OT-led counseling based on home activity pattern
Counseling: OT led counseling | 51 |
| Wait-listed Usual activity during the study. At the end of the study, will receive OT-led counseling
Usual education: At the end of the study, will receive OT-led counseling | 52 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete home monitoring activities after baseline visit | 9 | 4 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Participant did not have diabetes | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | Wait-listed | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 47 Participants | 96 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 2 Participants |
| Age, Continuous | 71.54 years STANDARD_DEVIATION 6.73 | 72.14 years STANDARD_DEVIATION 6.18 | 72.83 years STANDARD_DEVIATION 5.55 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 85 Participants | 44 Participants |
| Region of Enrollment United States | 52 Participants | 103 Participants | 51 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 50 Participants | 101 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 2 / 52 | 0 / 52 | 1 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 | 0 / 52 |
Outcome results
Primary
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.
Time frame: 6 months
Population: Only participants who completed the home monitoring activities were included in the outcomes analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Physical Activity | 401.88 KCal/week | Standard Deviation 3909.59 |
| Wait-listed | Physical Activity | -263.81 KCal/week | Standard Deviation 4414.79 |
Comparison: We hypothesized that at the end of 6 months, the intervention group will have increased physical activity as measured by CHAMPS compared to the control group.p-value: =0.1895% CI: [-0.18, 0.97]Mixed Models Analysis
Primary
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.
Time frame: 6 months
Population: Only participants with completed surveys were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Social Participation | Ability to participate social roles and activities | -0.55 T-score | Standard Deviation 7.5 |
| Intervention | Social Participation | Satisfaction social roles | 0.18 T-score | Standard Deviation 7.47 |
| Intervention | Social Participation | Satisfaction discretionary social roles | 0.35 T-score | Standard Deviation 8.14 |
| Wait-listed | Social Participation | Satisfaction social roles | 0.63 T-score | Standard Deviation 8.43 |
| Wait-listed | Social Participation | Satisfaction discretionary social roles | 0.85 T-score | Standard Deviation 7.29 |
| Wait-listed | Social Participation | Ability to participate social roles and activities | -0.36 T-score | Standard Deviation 7.4 |
Comparison: We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in social roles.p-value: 0.1995% CI: [-5.45, 1.06]Mixed Models Analysis
Comparison: We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in discretionary social activities.p-value: 0.5795% CI: [-4.53, 2.48]Mixed Models Analysis
Comparison: We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by the survey on the ability to participate in social roles and activities.p-value: 0.1295% CI: [-5.52, 0.63]Mixed Models Analysis
Other Pre-specified
Physical Function
Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds).
Time frame: 6 months
Population: Only participants who completed the 6-months physical function assessment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Physical Function | 0.01 seconds | Standard Deviation 1.68 |
| Wait-listed | Physical Function | -0.25 seconds | Standard Deviation 2.69 |
Comparison: We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in timed up and go test.p-value: <0.0595% CI: [-3.97, -0.02]Mixed Models Analysis
Other Pre-specified
Physical Function
Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking. Positive changes means better outcomes for gait speed (meters per second).
Time frame: 6 months
Population: Only participants who completed the 6-months physical function assessment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Physical Function | 0.01 meter per second | Standard Deviation 0.14 |
| Wait-listed | Physical Function | 0.00 meter per second | Standard Deviation 0.11 |
Comparison: We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in gait speed.p-value: 0.0295% CI: [0.02, 0.2]Mixed Models Analysis
Other Pre-specified
Physical Function
Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes. Positive changes means better outcomes for six-minute walk (meters).
Time frame: 6 months
Population: Only participants who completed the 6-months physical function assessment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Physical Function | 4.23 meters | Standard Deviation 45.97 |
| Wait-listed | Physical Function | 5.19 meters | Standard Deviation 35.73 |
Comparison: We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in six-minute walk test.p-value: 0.0295% CI: [7.9, 72.17]Mixed Models Analysis