Diabetes, Impaired Glucose Tolerance, Obesity
Conditions
Keywords
Aging, Exercise, Impaired Glucose Tolerance, Obesity, Functional Status, Disability, Health Services Research, Randomized Controlled Trial, Diabetes, Adaptive Randomization Design
Brief summary
This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of a one-year physical activity counseling intervention on glucose metabolism and secondary outcomes compared to usual care.
Detailed description
IMPACT. Our proposed project will contribute to improved quality and efficiency of VA health care by: (1) providing an effective program of Enhanced Fitness counseling that will result in a significant increase in physical activity of sufficient magnitude to achieve noted improvements in glycemic control, and (2) developing and disseminating materials that can be used throughout the VHA for physical activity promotion for older, overweight adults. BACKGROUND. The nation is experiencing a marked increase in obesity, and diabetes. Users of the VA medical facilities report higher than national average rates of obesity and diabetes. Current projections indicate that 70% of veterans using the VA medical care are overweight, 20% have diabetes, and 30- 40 % have metabolic syndrome. Approximately 30 % of VA health care costs are attributable to care for diabetes alone. Incidence and prevalence of these conditions increase with age and are associated with high medical costs. This is especially true of the older adult who typically has added comorbidities and functional limitations. The VHA has aggressively addressed the existing epidemic by implementing various programs and performance measures aimed at attaining optimal medical management of dyslipidemia, diabetes, and obesity. The component of all of these initiatives that has received the least amount of attention is physical activity despite overwhelming evidence that physical activity can favorably alter all of the medical conditions described above. The VA system-wide has been ill equipped to provide feasible, cost effective physical activity programs despite the imperative to seek ways to reduce incident diabetes and reduce potential health care costs. OBJECTIVES. We propose an innovative home-based enhanced fitness counseling intervention that involves a unique partnership between veteran, primary care provider, and exercise counselor directed at the older adult. The proposed project, Enhanced Fitness, seeks to improve glycemic control in older, overweight adults with impaired fasting glucose receiving primary care at the VA. A novel design, adaptive randomization, will allow us to assess the impact of our intervention at an early stage and then reassign individuals to a more intense or reduced intervention based upon patient compliance. Due to the national implementation of MOVE! in primary care for the treatment of obesity we will consider MOVE! as part of usual care for this population. Primary Hypothesis. Compared to usual care (plus MOVE!), individuals receiving Enhanced Fitness counseling will have significantly improved glucose metabolism (fasting insulin). Secondary Research Hypotheses and Objectives. (1) Compared to usual care (plus MOVE!), individuals receiving Enhanced Fitness counseling will have significantly improved secondary outcomes related glycemic control (fasting blood glucose, HOMA-IR, HbA1c, metabolic syndrome score), physical function (self report and physical performance), disability, and health related quality of life; and (2) To determine differences in cost and health care utilization between groups. Note: 7/5/2010: An amendment was submitted and approved to drop the adaptive randomization component of the study. This was necessary due to low levels of noncompliance observed during the first follow-up assessment. The primary and secondary objectives of the study were not affected by this amendment. Another amendment was submitted and approved to: 1) evaluate the association between APOE, diabetic risk and physical function; and 2) to examine associations between inflammatory markers, diabetic risk, and physical function. METHODS: For the proposed study we will target older adults (ages 60 and over) who are overweight (body mass index \>24-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of our 1-year Enhanced Fitness counseling intervention on glucose metabolism. A novel design, adaptive randomization, will allow us to mimic primary care by altering treatment based upon patient compliance. We will use a train the trainers approach for dissemination of results at the local, VISN, and national level.
Interventions
BEHAVIORALPhysical Activity Counseling
Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* VA patients followed by the Durham VA Primary Care, Women's Health, and Geriatric clinics * Must have had more than one visit to the VA in preceding 12 months * Age 60 and over * Impaired glucose intolerance documented by recent fasting blood glucose between 100 and 125 mg/dL * Body mass index between 25-40 kg/m2 * Able to walk 10 meters without human assistance (assistive device acceptable) * All participants must be assigned a primary care provider and have had more than one visit to the VA in the preceding 12 months
Exclusion criteria
* Free of frank diabetes * Fasting blood sugar above 125 mg/dL * HbA1c \> 7% * Unstable angina * Recent history of ventricular tachycardia * Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen) * Uncontrolled hypertension (diastolic blood pressure \>110 mm/Hg or systolic \> 200mm/Hg) * Stroke with moderate to severe aphasia * Diagnosis of chronic pain which may interfere with their ability to be physically active * Diagnosis of unstable mental or behavioral disorder * Diagnosis of memory loss or dementia * Visual or hearing loss severe enough to interfere with ability to receive telephone counseling and review written materials * Active substance abuse * A terminal diagnosis * Followed by VA for medications only * Regularly, vigorously physically active for six months or longer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Fasting Insulin | 12 months | — |
| Fasting Insulin | Baseline | Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws. |
| 3 Month Fasting Insulin | 3 month | — |
| 12 Month Fasting Glucose | 12 Months | — |
| Fasting Glucose | Baseline | — |
| 3 Month Fasting Glucose | 3 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity, Endurance | Baseline | Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Physical Activity Counseling Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.
Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback. | 180 |
| Arm 2 Usual care from primary, womens or geriatric clinics | 122 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Initial 3 Month Counseling | Family illness | 1 | 0 | 0 |
| Initial 3 Month Counseling | Lack of Interest | 3 | 3 | 0 |
| Initial 3 Month Counseling | Moved | 1 | 0 | 0 |
| Initial 3 Month Counseling | Not ready to exercise | 1 | 0 | 0 |
| Initial 3 Month Counseling | Pain | 2 | 0 | 0 |
| Initial 3 Month Counseling | Personal issues | 2 | 0 | 0 |
| Initial 3 Month Counseling | Too busy | 7 | 1 | 0 |
| Rerandomization Arm 1 Only | Death | 2 | 1 | 0 |
| Rerandomization Arm 1 Only | Withdrawal by Subject | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Arm 1 Physical Activity Counseling | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 6.3 | 67.7 years STANDARD_DEVIATION 6.2 | 67.2 years STANDARD_DEVIATION 6.1 |
| Physical Function | 62.94 points STANDARD_DEVIATION 20.97 | 63.97 points STANDARD_DEVIATION 21.79 | 62.98 points STANDARD_DEVIATION 21 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 39 Participants | 88 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 129 Participants | 83 Participants | 212 Participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 173 Participants | 119 Participants | 292 Participants |
| usual gait speed | 1.24 meters/second STANDARD_DEVIATION 0.3 | 1.25 meters/second STANDARD_DEVIATION 0.3 | 1.24 meters/second STANDARD_DEVIATION 0.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 158 / 180 | 50 / 122 |
| serious Total, serious adverse events | 26 / 180 | 11 / 122 |
Outcome results
Primary
12 Month Fasting Glucose
Time frame: 12 Months
Population: All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | 12 Month Fasting Glucose | 104.35 mg/dl | Standard Deviation 9.62 |
| Arm 2 | 12 Month Fasting Glucose | 104.38 mg/dl | Standard Deviation 11.97 |
p-value: 0.91Mixed Models Analysis
Primary
12 Month Fasting Insulin
Time frame: 12 months
Population: All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | 12 Month Fasting Insulin | 11.4 uIU/ml | Standard Deviation 6.84 |
| Arm 2 | 12 Month Fasting Insulin | 10.28 uIU/ml | Standard Deviation 5.59 |
p-value: 0.43Mixed Models Analysis
Primary
3 Month Fasting Glucose
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | 3 Month Fasting Glucose | 106.96 mg/dl | Standard Deviation 9.59 |
| Arm 2 | 3 Month Fasting Glucose | 107.63 mg/dl | Standard Deviation 9.62 |
Primary
3 Month Fasting Insulin
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | 3 Month Fasting Insulin | 10.04 uIU/ml | Standard Deviation 7.21 |
| Arm 2 | 3 Month Fasting Insulin | 10.45 uIU/ml | Standard Deviation 7.82 |
Primary
Fasting Glucose
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | Fasting Glucose | 110.51 mg/dl | Standard Deviation 6.95 |
| Arm 2 | Fasting Glucose | 110.6 mg/dl | Standard Deviation 7.1 |
Primary
Fasting Insulin
Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | Fasting Insulin | 10.26 uIU/ml | Standard Deviation 6.09 |
| Arm 2 | Fasting Insulin | 10.39 uIU/ml | Standard Deviation 8.58 |
Secondary
Physical Activity, Endurance
Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | Physical Activity, Endurance | 73.39 minutes per week | Standard Deviation 119.81 |
| Arm 2 | Physical Activity, Endurance | 115.29 minutes per week | Standard Deviation 183.66 |
Secondary
Physical Activity, Endurance
Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | Physical Activity, Endurance | 124.3 minutes per week | Standard Deviation 127.15 |
| Arm 2 | Physical Activity, Endurance | 92.87 minutes per week | Standard Deviation 115.01 |
Secondary
Physical Activity, Endurance
Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Time frame: 12 Months
Population: All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Physical Activity Counseling | Physical Activity, Endurance | 133.6 minutes per week | Standard Deviation 136.47 |
| Arm 2 | Physical Activity, Endurance | 112.62 minutes per week | Standard Deviation 135.45 |
p-value: <0.001Mixed Models Analysis