Clinical trial NCT00594399: Enhancing Fitness in Older Pre-diabetic Veterans
Official title: Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Impaired Glucose Tolerance
Obesity
Diabetes
Keywords: Aging
Exercise
Impaired Glucose Tolerance
Obesity
Functional Status
Disability
Health Services Research
Randomized Controlled Trial
Diabetes
Adaptive Randomization Design
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-01-15
Enrollment: 302
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting Insulin
timeFrame: Baseline
measure: 3 Month Fasting Insulin
timeFrame: 3 month
measure: 12 Month Fasting Insulin
timeFrame: 12 months
measure: Fasting Glucose
timeFrame: Baseline
measure: 3 Month Fasting Glucose
timeFrame: 3 months
measure: 12 Month Fasting Glucose
timeFrame: 12 Months
Secondary outcomes:
measure: Physical Activity, Endurance
timeFrame: Baseline
measure: Physical Activity, Endurance
timeFrame: 3 months
measure: Physical Activity, Endurance
timeFrame: 12 Months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Miriam C. Morey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turer CB, Bernstein IH, Edelman DE, Yancy WS Jr. Low HDL predicts differential blood pressure effects from two weight-loss approaches: a secondary analysis of blood pressure from a randomized, clinical weight-loss trial. Diabetes Obes Metab. 2012 Apr;14(4):375-8. doi: 10.1111/j.1463-1326.2011.01531.x. Epub 2011 Dec 27.
citation: Morey MC, Pieper CF, Edelman DE, Yancy WS Jr, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Hall KS, Pearson MP, Taylor GA. Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus. J Am Geriatr Soc. 2012 Sep;60(9):1655-62. doi: 10.1111/j.1532-5415.2012.04119.x.
citation: Hall KS, Pieper CF, Edelman DE, Yancy WS Jr, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Chapman JG, Pearson MP, Howard TA, Ekelund CC, McCraw BL, Burrell JB, Taylor GA, Morey MC. Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study. Transl Behav Med. 2011 Nov;1(4):573-587. doi: 10.1007/s13142-011-0075-6.
citation: Povsic TJ, Sloane R, Green JB, Zhou J, Pieper CF, Pearson MP, Peterson ED, Cohen HJ, Morey MC. Depletion of circulating progenitor cells precedes overt diabetes: a substudy from the VA enhanced fitness trial. J Diabetes Complications. 2013 Nov-Dec;27(6):633-6. doi: 10.1016/j.jdiacomp.2013.08.004. Epub 2013 Sep 19.
citation: Hall KS, Beckham JC, Bosworth HB, Sloane R, Pieper CF, Morey MC. PTSD is negatively associated with physical performance and physical function in older overweight military Veterans. J Rehabil Res Dev. 2014;51(2):285-95. doi: 10.1682/JRRD.2013.04.0091.
citation: Povsic TJ, Sloane R, Zhou J, Pieper CF, Pearson MP, Peterson ED, Green JB, Cohen HJ, Morey MC. Lower levels of circulating progenitor cells are associated with low physical function and performance in elderly men with impaired glucose tolerance: a pilot substudy from the VA Enhanced Fitness trial. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1559-66. doi: 10.1093/gerona/glt067. Epub 2013 May 16.
citation: Povsic TJ, Sloane R, Pieper CF, Pearson MP, Peterson ED, Cohen HJ, Morey MC. Endothelial Progenitor Cell Levels Predict Future Physical Function: An Exploratory Analysis From the VA Enhanced Fitness Study. J Gerontol A Biol Sci Med Sci. 2016 Mar;71(3):362-9. doi: 10.1093/gerona/glv180. Epub 2015 Oct 28.