Enhancing Fitness in Older Pre-diabetic Veterans

April 6, 2015 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center, Durham, NC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
3 Month Fasting Insulin
Time Frame: 3 month
3 month
12 Month Fasting Insulin
Time Frame: 12 months
12 months
Fasting Glucose
Time Frame: Baseline
Baseline
3 Month Fasting Glucose
Time Frame: 3 months
3 months
12 Month Fasting Glucose
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity, Endurance
Time Frame: Baseline
Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Baseline
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.
3 months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Miriam C. Morey, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 06-252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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