Enhancing Fitness in Older Pre-diabetic Veterans
Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose
1 other identifier
interventional
302
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
January 9, 2015
CompletedApril 27, 2015
August 1, 2014
2.4 years
January 3, 2008
October 1, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Baseline
3 Month Fasting Insulin
3 month
12 Month Fasting Insulin
12 months
Fasting Glucose
Baseline
3 Month Fasting Glucose
3 months
12 Month Fasting Glucose
12 Months
Secondary Outcomes (3)
Physical Activity, Endurance
Baseline
Physical Activity, Endurance
3 months
Physical Activity, Endurance
12 Months
Study Arms (2)
Arm 1 Physical Activity counseling
EXPERIMENTALPhysical 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.
Arm 2
NO INTERVENTIONUsual care from primary, womens or geriatric clinics
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
Related Publications (7)
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.
PMID: 22059803RESULTMorey 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.
PMID: 22985140RESULTHall 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.
PMID: 22866170RESULTPovsic 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.
PMID: 24055327RESULTHall 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.
PMID: 24933726RESULTPovsic 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.
PMID: 23682163RESULTPovsic 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.
PMID: 26511012DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Miriam C. Morey, Ph.D.
- Organization
- Durham VA Medical Center (GRECC/HSRD)
Study Officials
- PRINCIPAL INVESTIGATOR
Miriam C. Morey, PhD
Durham VA Medical Center, Durham, NC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2008
First Posted
January 15, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
April 27, 2015
Results First Posted
January 9, 2015
Record last verified: 2014-08