Enhancing Fitness in Older Pre-diabetic Veterans

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: January 8, 2015
Last verified: January 2015
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Impaired Glucose Tolerance
Obesity
Diabetes
Intervention: Behavioral: Physical Activity Counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

Arm 2, Usual Care Usual care from primary, womens or geriatric clinics
Arm 3, Physical Activity Counseling, Reduced Dose Upon rerandomization, individuals in this group continued to receive monthly physical activity counseling through 6 months which was then reduced to every other month during months 6-12.

Participant Flow for 2 periods

Period 1:   Initial 3 Month Counseling
    Arm 1 Physical Activity Counseling     Arm 2, Usual Care     Arm 3, Physical Activity Counseling, Reduced Dose  
STARTED     180     122     0  
COMPLETED     163     118     0  
NOT COMPLETED     17     4     0  
Not ready to exercise                 1                 0                 0  
Lack of Interest                 3                 3                 0  
Personal issues                 2                 0                 0  
Too busy                 7                 1                 0  
Pain                 2                 0                 0  
Moved                 1                 0                 0  
Family illness                 1                 0                 0  

Period 2:   Rerandomization Arm 1 Only
    Arm 1 Physical Activity Counseling     Arm 2, Usual Care     Arm 3, Physical Activity Counseling, Reduced Dose  
STARTED     81 [1]   118     82 [2]
Rerandomization     81 [3]   114     82  
COMPLETED     79     114     82  
NOT COMPLETED     2     4     0  
Death                 2                 1                 0  
Withdrawal by Subject                 0                 3                 0  
[1] Total sample in Arm 1 was rerandomized and allocated to remain in Arm 1 or assigned to Arm 3
[2] This sample reflects newly randomized study Arm
[3] Rerandomized to continue to receive telephone calls every 2 weeks or at a reduced dose of 1/ month



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The average age of the sample was 67 year with a range of 60 to 89. Participant were in a normal usual walking speed for their ages but were at the 10th percentile in norms for six-minute walk distance indicating poor aerobic capacity for their age.

Reporting Groups
  Description
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.

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.

Arm 2 Usual care from primary, womens or geriatric clinics
Total Total of all reporting groups

Baseline Measures
    Arm 1 Physical Activity Counseling     Arm 2     Total  
Number of Participants  
[units: participants]
  180     122     302  
Age  
[units: years]
Mean ± Standard Deviation
  67.1  ± 6.3     67.7  ± 6.2     67.2  ± 6.1  
Gender  
[units: participants]
     
Female     7     3     10  
Male     173     119     292  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     49     39     88  
White     129     83     212  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
usual gait speed [1]
[units: meters/second]
Mean ± Standard Deviation
  1.24  ± 0.3     1.25  ± 0.3     1.24  ± 0.3  
Physical Function [2]
[units: points]
Mean ± Standard Deviation
  62.94  ± 20.97     63.97  ± 21.79     62.98  ± 21.0  
[1] Normal walking speed over 4 meters
[2] Physical function was measured by self report using the physical function subscale of the SF-36. Scores range from 0 to 100 with a higher score indicating better functioning.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fasting Insulin   [ Time Frame: Baseline ]

2.  Primary:   3 Month Fasting Insulin   [ Time Frame: 3 month ]

3.  Primary:   12 Month Fasting Insulin   [ Time Frame: 12 months ]

4.  Primary:   Fasting Glucose   [ Time Frame: Baseline ]

5.  Primary:   3 Month Fasting Glucose   [ Time Frame: 3 months ]

6.  Primary:   12 Month Fasting Glucose   [ Time Frame: 12 Months ]

7.  Secondary:   Physical Activity, Endurance   [ Time Frame: Baseline ]

8.  Secondary:   Physical Activity, Endurance   [ Time Frame: 3 months ]

9.  Secondary:   Physical Activity, Endurance   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Miriam C. Morey, Ph.D.
Organization: Durham VA Medical Center (GRECC/HSRD)
phone: 919-286-0411 ext 6776
e-mail: miriam.morey@va.gov


Publications of Results:


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
Results First Received: October 1, 2014
Last Updated: January 8, 2015
Health Authority: United States: Federal Government