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The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults (PRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192475
Recruitment Status : Completed
First Posted : June 20, 2017
Results First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Venditti, University of Pittsburgh

Brief Summary:
The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12 month outcome data (with a no treatment follow-up assessment at 24 months) to help determine whether a continued contact group telephone intervention is feasible and effective in enhancing health outcomes and physical functional ability in high risk adults (aged 65-80) with obesity and cardiometabolic risk factors .

Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Risk Factor Eating Behavior Diet Modification Physical Activity Quality of Life Mobility Limitation Behavioral: GLB plus phone contacts Behavioral: GLB plus newsletter contacts Not Applicable

Detailed Description:
There is substantial evidence that overweight and obesity during late life (≥ 65 years of age) confers significant risk for type 2 diabetes and co-morbid conditions. Thus, there is growing concern about the public health consequences of increased incidence of type 2 diabetes in an aging United States population. Studies with high risk samples have shown that lifestyle interventions significantly reduce diabetes risk and that elders are particularly responsive, showing better weight loss and lower rates of diabetes development in comparison to younger individuals. However, although there have been program dissemination studies with mixed-age adult cohorts, few studies have focused specifically on persons ≥ 65 years of age or addressed the challenges of identifying workable platforms for delivering prevention programs to older adults. This application is based on the premise that offering an evidence-based lifestyle intervention to reduce risk for type 2 diabetes to retirees during the annual Medicare enrollment process presents an innovative, practical opportunity to reach eligible, high-risk adults. If shown to be feasible and effective, this program has strong potential for public health impact and medical cost-containment. Further, although clinical studies have emphasized the importance of continued contact over time in helping individuals extend the benefits of lifestyle interventions, there are no dissemination studies of which we are aware that have systematically documented the impact of continued monthly contacts after the initial intervention period. Thus, the overall aims of this application are to: 1. examine the feasibility and effectiveness of implementing the Group Lifestyle Balance 12-session program (GLB-12), an evidence-supported prevention program to mitigate diabetes risk, as part of the Medicare benefit offered to high risk retirees at a large public university, and; 2. evaluate the utility of continued telephone contact in enhancing treatment outcome at 12-months from baseline. Eligible participants will be 320 adults without diabetes, aged 65-80, with a BMI ≥ 27 and at least one additional cardiometabolic risk factor. All participants will receive the GLB-12 and then will be randomized to one of two continued contact protocols for the remaining one year of intervention, 8-sessions of continued small group contact by telephone (GLB-12 plus 8TC) or a newsletter control condition (GLB-12 plus NC). Program feasibility will be assessed by reporting enrollment, adherence and session completion rates, and satisfaction ratings in this delivery context. Effectiveness of the GLB-12 will be documented by reporting mean percent weight loss and the proportion of participants meeting ≥ 5% weight loss, a commonly accepted benchmark in translation studies known to be associated with favorable cardiometabolic outcomes at month 4. It also is hypothesized that GLB-12 plus 8TC, when compared to GLB-12 plus NC will be associated with more favorable anthropometric (weight, waist), cardiometabolic (glucose, blood pressure, lipid), physical function (chair stand, balance, gait speed) and health related quality of life outcomes at months 12 and 24. Finally, exploratory analyses will document program costs and program impact on medical utilization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An initial (non-randomized) translational Group Lifestyle Balance (GLB) in person, lifestyle intervention designed to mitigate cardiometabolic risk in older adults is delivered to all participants between 0 and 4-months. Subsequently, one-half of the enrolled sample is randomized to either (1) 8-group telephone contacts (8-TC) for the remainder of 12-months; the other one-half is randomized to a newsletter control condition (NC) during this time period.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dissemination of a Diabetes Prevention Program Among Medicare Eligible Older Adults
Actual Study Start Date : January 28, 2013
Actual Primary Completion Date : May 26, 2017
Actual Study Completion Date : May 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicare

Arm Intervention/treatment
Active Comparator: Group Lifestyle Balance plus phone contacts
Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months
Behavioral: GLB plus phone contacts
GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving.

Placebo Comparator: Group Lifestyle Balance plus newsletter contacts
Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months.
Behavioral: GLB plus newsletter contacts
GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only.




Primary Outcome Measures :
  1. Change in Bodyweight [ Time Frame: Change from baseline bodyweight at 12-months ]
    Bodyweight of participant.


Secondary Outcome Measures :
  1. Change in Waist Circumference [ Time Frame: Change from baseline circumference at 12-months ]
    Waist circumference measured with a spring-loaded tape measure.

  2. Change in Fasting Total Cholesterol [ Time Frame: Change from baseline level at 12-months ]
    Total cholesterol (mg/dl) measured by finger-stick blood sample

  3. Change in Fasting High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Change from baseline level at 12-months ]
    HDL-cholesterol (mg/dl) measured by finger-stick blood sample

  4. Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol [ Time Frame: Change from baseline level at 12-months ]
    LDL-cholesterol (mg/dl) measured by finger-stick blood sample

  5. Change in Fasting Triglycerides [ Time Frame: Change from baseline level at 12-months ]
    Triglycerides (mg/dl) measured by fasting finger-stick sample

  6. Change in Fasting Glucose [ Time Frame: Change from baseline level at 12-months ]
    Fasting glucose (mg/dl) measured by finger-stick sample

  7. Change in Systolic Blood Pressure [ Time Frame: Change from baseline level at 12-months ]
    Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)

  8. Change in Diastolic Blood Pressure (mmHg) [ Time Frame: Change from baseline value at 12 months ]
    Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)

  9. Change in Physical Function Performance Battery [ Time Frame: Change from baseline score at 12-months ]

    Short Physical Performance Battery (SPPB) total score (0-12) includes three function tests (each scored 0-4) and summed.

    The subtests are (1) gait speed measured in meters/second on a 4-meter walk route; (2) 3 progressive standing balance tests; (3) 5 chair stands. Higher score indicates better physical function.


  10. Change in Physical Activity Minutes/Week Using All CHAMPS Items [ Time Frame: Change from baseline minutes/week at 12-months ]
    Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults

  11. Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week [ Time Frame: percentage reporting higher intensity level activities 3 times per week or more at 12 months ]

    Stanford Brief Physical Activity categorical measure:

    Queries amount and intensity of typical weekly activities over the past month.

    1. most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month.
    2. most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home.
    3. at least 3 times per week reports moderate activity such as brisk walking for 15-20 minutes or more, or at least 45-60 minutes of heavy home and yard chores.
    4. at least 3 times per week reports a regular program of moderate-vigorous intensity physical activities, or a regular program of fitness for 30 minutes or more, or active games like handball or tennis, or heavy home and yard chores for 60-minutes or more.

    Participants that endorse items 3 or 4 were considered to have achieved 3 or more days of moderate intensity physical activities per week.


  12. Change in Health Related Quality of Life-physical Component Summary Score [ Time Frame: Change from baseline score at 12-months ]
    Short-form 12-item health status questionnaire produces two scores: a physical component summary score and a mental component summary score. Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10.

  13. Change in Nutrition [ Time Frame: change from baseline score at 12-months ]
    Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet.

  14. Change in Mood [ Time Frame: change from baseline score at 12-months ]
    Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women, ages 65-80, with a BMI ≥ 27 and at least one of the following additional risk factors will be included: 1) Large waist circumference (> 40 inches men, >35 inches women) 2) hypertension or taking hypertension medication; 3) elevated lipids or taking medication for lipids or triglycerides 4) pre-diabetes (fasting glucose ≥ 100 mg/dL and < 126 mg/DL OR 5) or a score of 15 on the American Diabetes Association (ADA) risk test.

All study participants must have access to a telephone (including appropriate assistive devices if there are hearing impairments) and be able to read at the 6th grade level.

Exclusion Criteria:

  • Individuals who report that they have been diagnosed by their doctor with diabetes or that they are taking any medicines used to treat diabetes
  • lack of physician clearance for exercise participation before the 4th session
  • a weight loss of 4.5 kgs or more in the past six months (to rule out unintentional weight loss that may be an indicator of current or incipient physical illness)
  • current use of weight loss medications
  • unable to attend at least 75% of the GLB 12-session program or are unwilling to self-monitor food, activity and weight as prescribed will be excluded and encouraged to consider joining in subsequent years.

Excluded individuals are referred to other clinical resources as appropriate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192475


Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Elizabeth M Venditti, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Elizabeth Venditti, University of Pittsburgh:
Informed Consent Form  [PDF] March 17, 2015

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Responsible Party: Elizabeth Venditti, Assistant Professor of Psychiatry and Epidemiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03192475    
Other Study ID Numbers: PRO12050022
First Posted: June 20, 2017    Key Record Dates
Results First Posted: November 13, 2019
Last Update Posted: November 13, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the time of this R18 application in 2011 and resubmission and funding in 2012, a formal data sharing plan was neither required nor proposed. However, I will share final IPD with interested colleagues (including post-doctoral students and junior faculty, co-investigators at my institution across several departments including Medicine, Psychiatry, Epidemiology/Public Health). All data is de-identified per the original Data Safety and Monitoring Plan. All safeguards will be taken to ensure confidentiality and privacy of participants. I will not place limits on questions or methods of those sharing data files and only require that the Pitt Retiree Study participants and primary manuscripts resulting from this work, be acknowledged on all abstracts and manuscript publications resulting from the final data set.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The IPD, study protocol, informed consent form, and clinical study report will be available starting May 2019. No end date is specified.
Access Criteria:

Contact the Principal Investigator directly at:

vendittiem@upmc.edu


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms