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

Not Applicable

Completed

Conditions: Quality of Life
Mobility Limitation
Cardiovascular Risk Factor
Eating Behavior
Physical Activity
Diet Modification
Obesity

Interventions: Behavioral: GLB plus phone contacts
Behavioral: GLB plus newsletter contacts

Registration Number: NCT03192475

Lead Sponsor: 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 .

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 322

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Lifestyle Balance plus phone contacts	GLB 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
Group Lifestyle Balance plus newsletter contacts	GLB 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.

Primary Outcome Measures

Name	Time	Method
Change in Bodyweight	Change from baseline bodyweight at 12-months	Bodyweight of participant.

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Total Cholesterol	Change from baseline level at 12-months	Total cholesterol (mg/dl) measured by finger-stick blood sample
Change in Health Related Quality of Life-physical Component Summary Score	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.
Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol	Change from baseline level at 12-months	LDL-cholesterol (mg/dl) measured by finger-stick blood sample
Change in Fasting Triglycerides	Change from baseline level at 12-months	Triglycerides (mg/dl) measured by fasting finger-stick sample
Change in Diastolic Blood Pressure (mmHg)	Change from baseline value at 12 months	Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
Change in Physical Activity Minutes/Week Using All CHAMPS Items	Change from baseline minutes/week at 12-months	Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults
Change in Physical Function Performance Battery	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.
Change in Waist Circumference	Change from baseline circumference at 12-months	Waist circumference measured with a spring-loaded tape measure.
Change in Fasting High-Density Lipoprotein (HDL) Cholesterol	Change from baseline level at 12-months	HDL-cholesterol (mg/dl) measured by finger-stick blood sample
Change in Fasting Glucose	Change from baseline level at 12-months	Fasting glucose (mg/dl) measured by finger-stick sample
Change in Systolic Blood Pressure	Change from baseline level at 12-months	Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week	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.
Change in Nutrition	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.
Change in Mood	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)