Veterans Enhanced Fitness Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Impaired Glucose Tolerance Obesity Diabetes	Behavioral: Physical Activity Counseling	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Obesity

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Improved insulin action as measured by fasting insulin, fasting glucose and by HOMAR-IR [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	October 2008
Study Completion Date:	June 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
No Intervention: Arm 2 Usual care

Arms

Assigned Interventions

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.

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.

No Intervention: Arm 2

Usual care

Show Detailed Description

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594399

Locations

United States, North Carolina
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Miriam C. Morey, PhD

Department of Veterans Affairs

More Information

Publications:

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.

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.

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.

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00594399 History of Changes
Other Study ID Numbers:	IIR 06-252
Study First Received:	January 3, 2008
Last Updated:	April 18, 2013
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Aging
Exercise
Impaired Glucose Tolerance
Obesity
Functional Status

Disability
Health Services Research
Randomized Controlled Trial
Diabetes
Adaptive Randomization Design

Additional relevant MeSH terms:

Diabetes Mellitus
Obesity
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia

ClinicalTrials.gov processed this record on May 23, 2013