Enhancing Fitness in Older Pre-diabetic Veterans | NCT00594399

NCT00594399

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 Physical Activity counseling	Experimental	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
Arm 2	No Intervention	Usual care from primary, womens or geriatric clinics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical Activity Counseling	Behavioral	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Module

Name	Affiliation	Role
Miriam C. Morey, PhD	Durham VA Medical Center, Durham, NC	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Durham VA Medical Center, Durham, NC		Durham	North Carolina	27705	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22059803	Result	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.
22985140	Result

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Arm 2, Usual Care	Usual care from primary, womens or geriatric clinics
FG002	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.

Periods

Title

Milestones

Reasons Not Completed

Initial 3 Month Counseling

Type	Comment	Milestone Data
STARTED		FG000180 subjects FG001122 subjects FG0020 subjects
COMPLETED		FG000163 subjects FG001118 subjects FG0020 subjects
NOT COMPLETED		FG00017 subjects FG0014 subjects FG0020 subjects

Type	Comment	Reasons
Not ready to exercise		FG0001 subjects FG0010 subjects FG0020 subjects
Lack of Interest		FG000

Rerandomization Arm 1 Only

Type	Comment	Milestone Data
STARTED		FG00081 subjectsTotal sample in Arm 1 was rerandomized and allocated to remain in Arm 1 or assigned to Arm 3 FG001118 subjects FG00282 subjectsThis sample reflects newly randomized study Arm
Rerandomization

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Fasting Insulin

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.

Posted

Mean

Standard Deviation

uIU/ml

Baseline

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
The patient experienced dizziness and radiating shoulder pain	Cardiac disorders		Systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pt has been "hibernating" for 3 weeks- not feeling well and spending most time in bed	Psychiatric disorders		Systematic Assessment

Title	Organization	Phone	Extension	Email
Miriam C. Morey, Ph.D.	Durham VA Medical Center (GRECC/HSRD)	919-286-0411	6776	miriam.morey@va.gov

Condition Browse Module

ID	Term
D018149	Glucose Intolerance
D009765	Obesity
D003920	Diabetes Mellitus
D009043	Motor Activity

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases