Enhancing Fitness in Older Pre-diabetic Veterans
|ClinicalTrials.gov Identifier: NCT00594399|
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : January 9, 2015
Last Update Posted : April 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Impaired Glucose Tolerance Obesity Diabetes||Behavioral: Physical Activity Counseling||Phase 2 Phase 3|
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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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose|
|Study Start Date :||October 2008|
|Primary Completion Date :||March 2011|
|Study Completion Date :||June 2011|
Experimental: 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.
Behavioral: 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.
No Intervention: Arm 2
Usual care from primary, womens or geriatric clinics
- Fasting Insulin [ Time Frame: 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 [ Time Frame: 3 month ]
- 12 Month Fasting Insulin [ Time Frame: 12 months ]
- Fasting Glucose [ Time Frame: Baseline ]
- 3 Month Fasting Glucose [ Time Frame: 3 months ]
- 12 Month Fasting Glucose [ Time Frame: 12 Months ]
- Physical Activity, Endurance [ Time Frame: Baseline ]Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
- Physical Activity, Endurance [ Time Frame: 3 months ]Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
- Physical Activity, Endurance [ Time Frame: 12 Months ]Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594399
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Miriam C. Morey, PhD||Durham VA Medical Center, Durham, NC|