Veterans Enhanced Fitness Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00594399
First received: January 3, 2008
Last updated: February 6, 2014
Last verified: October 2011

January 3, 2008
February 6, 2014
October 2008
March 2011   (final data collection date for primary outcome measure)
Improved insulin action as measured by fasting insulin, fasting glucose and by HOMAR-IR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Improved insulin action as measured by fasting insulin, fasting glucose and by HOMAR-IR [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00594399 on ClinicalTrials.gov Archive Site
Secondary outcomes of glycemic control (Hemoglobin A1c, metabolic syndrome score), physical activity, physical function, health QOL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary outcomes of glycemic control (Hemoglobin A1c, metabolic syndrome score), physical activity, physical function, health QOL [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Veterans Enhanced Fitness Study
Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Impaired Glucose Tolerance
  • Obesity
  • Diabetes
Behavioral: Physical Activity Counseling
Physical activity (PA) counseling program with the following components: (1) a baseline in-person counseling session; (2) telephone calls biweekly for 6 weeks then monthly; (3) one physician endorsement of PA in a primary care clinic visit; (4) monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback. At 3-month individuals in the experimental arm will be re-randomized based on adherence to PA (adaptive design). Individuals categorized at non-adherent will be offered group cognitive behavioral therapy to enhance PA uptake. Individuals categorized as adherent will randomly assigned to two doses of telephone counseling calls for the duration of the trial. Note: 7/5/2010: An amendment was approved to drop the adaptive randomization component of the study due to low levels of non-adherence observed during the first follow-up assessment. The objectives of the study were not affected by this change.
  • Experimental: Arm 1
    Physical activity (PA) counseling program with the following components: (1) a baseline in-person counseling session; (2) telephone calls biweekly for 6 weeks then monthly; (3) one physician endorsement of PA in a primary care clinic visit; (4) monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback. At 3-month individuals in the experimental arm will be re-randomized based on adherence to PA (adaptive design). Individuals categorized at non-adherent will be offered group cognitive behavioral therapy to enhance PA uptake. Individuals categorized as adherent will randomly assigned to two doses of telephone counseling calls for the duration of the trial. Note: 7/5/2010: An amendment was approved to drop the adaptive randomization component of the study due to low levels of non-adherence observed during the first follow-up assessment. The objectives of the study were not affected by this change.
    Intervention: Behavioral: Physical Activity Counseling
  • No Intervention: Arm 2
    Usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594399
IIR 06-252
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Miriam C. Morey, PhD Department of Veterans Affairs
Department of Veterans Affairs
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP