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

Primary Purpose

Obesity, Cardiovascular Risk Factor, Eating Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GLB plus phone contacts
GLB plus newsletter contacts
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group Lifestyle Balance plus phone contacts

    Group Lifestyle Balance plus newsletter contacts

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Change in Bodyweight
    Bodyweight of participant.

    Secondary Outcome Measures

    Change in Waist Circumference
    Waist circumference measured with a spring-loaded tape measure.
    Change in Fasting Total Cholesterol
    Total cholesterol (mg/dl) measured by finger-stick blood sample
    Change in Fasting High-Density Lipoprotein (HDL) Cholesterol
    HDL-cholesterol (mg/dl) measured by finger-stick blood sample
    Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol
    LDL-cholesterol (mg/dl) measured by finger-stick blood sample
    Change in Fasting Triglycerides
    Triglycerides (mg/dl) measured by fasting finger-stick sample
    Change in Fasting Glucose
    Fasting glucose (mg/dl) measured by finger-stick sample
    Change in Systolic Blood Pressure
    Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
    Change in Diastolic Blood Pressure (mmHg)
    Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
    Change in Physical Function Performance Battery
    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.
    Change in Physical Activity Minutes/Week Using All CHAMPS Items
    Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults
    Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week
    Stanford Brief Physical Activity categorical measure: Queries amount and intensity of typical weekly activities over the past month. most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month. most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home. 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. 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.
    Change in Health Related Quality of Life-physical Component Summary Score
    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.
    Change in Nutrition
    Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet.
    Change in Mood
    Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms)

    Full Information

    First Posted
    June 15, 2017
    Last Updated
    October 25, 2019
    Sponsor
    University of Pittsburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03192475
    Brief Title
    The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults
    Acronym
    PRS
    Official Title
    Dissemination of a Diabetes Prevention Program Among Medicare Eligible Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 28, 2013 (Actual)
    Primary Completion Date
    May 26, 2017 (Actual)
    Study Completion Date
    May 26, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 .
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Cardiovascular Risk Factor, Eating Behavior, Diet Modification, Physical Activity, Quality of Life, Mobility Limitation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    322 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Lifestyle Balance plus phone contacts
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Group Lifestyle Balance plus newsletter contacts
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    GLB plus phone contacts
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    GLB plus newsletter contacts
    Intervention Description
    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 Measure Information:
    Title
    Change in Bodyweight
    Description
    Bodyweight of participant.
    Time Frame
    Change from baseline bodyweight at 12-months
    Secondary Outcome Measure Information:
    Title
    Change in Waist Circumference
    Description
    Waist circumference measured with a spring-loaded tape measure.
    Time Frame
    Change from baseline circumference at 12-months
    Title
    Change in Fasting Total Cholesterol
    Description
    Total cholesterol (mg/dl) measured by finger-stick blood sample
    Time Frame
    Change from baseline level at 12-months
    Title
    Change in Fasting High-Density Lipoprotein (HDL) Cholesterol
    Description
    HDL-cholesterol (mg/dl) measured by finger-stick blood sample
    Time Frame
    Change from baseline level at 12-months
    Title
    Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol
    Description
    LDL-cholesterol (mg/dl) measured by finger-stick blood sample
    Time Frame
    Change from baseline level at 12-months
    Title
    Change in Fasting Triglycerides
    Description
    Triglycerides (mg/dl) measured by fasting finger-stick sample
    Time Frame
    Change from baseline level at 12-months
    Title
    Change in Fasting Glucose
    Description
    Fasting glucose (mg/dl) measured by finger-stick sample
    Time Frame
    Change from baseline level at 12-months
    Title
    Change in Systolic Blood Pressure
    Description
    Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
    Time Frame
    Change from baseline level at 12-months
    Title
    Change in Diastolic Blood Pressure (mmHg)
    Description
    Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
    Time Frame
    Change from baseline value at 12 months
    Title
    Change in Physical Function Performance Battery
    Description
    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.
    Time Frame
    Change from baseline score at 12-months
    Title
    Change in Physical Activity Minutes/Week Using All CHAMPS Items
    Description
    Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults
    Time Frame
    Change from baseline minutes/week at 12-months
    Title
    Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week
    Description
    Stanford Brief Physical Activity categorical measure: Queries amount and intensity of typical weekly activities over the past month. most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month. most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home. 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. 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.
    Time Frame
    percentage reporting higher intensity level activities 3 times per week or more at 12 months
    Title
    Change in Health Related Quality of Life-physical Component Summary Score
    Description
    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.
    Time Frame
    Change from baseline score at 12-months
    Title
    Change in Nutrition
    Description
    Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet.
    Time Frame
    change from baseline score at 12-months
    Title
    Change in Mood
    Description
    Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms)
    Time Frame
    change from baseline score at 12-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth M Venditti, PhD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    IPD Sharing Time Frame
    The IPD, study protocol, informed consent form, and clinical study report will be available starting May 2019. No end date is specified.
    IPD Sharing Access Criteria
    Contact the Principal Investigator directly at: vendittiem@upmc.edu
    Citations:
    PubMed Identifier
    32918078
    Citation
    Venditti EM, Marcus MD, Miller RG, Arena VC, Greenspan SL, Rockette-Wagner B. Group Lifestyle Phone Maintenance for Weight, Health, and Physical Function in Adults Aged 65-80 Years: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Jan 18;76(2):352-360. doi: 10.1093/gerona/glaa229.
    Results Reference
    derived

    Learn more about this trial

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

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