Clinical trial NCT03192475: The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults
Official title: Dissemination of a Diabetes Prevention Program Among Medicare Eligible Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Risk Factor
Eating Behavior
Diet Modification
Physical Activity
Quality of Life
Mobility Limitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 322
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Bodyweight
timeFrame: Change from baseline bodyweight at 12-months
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Change from baseline circumference at 12-months
measure: Change in Fasting Total Cholesterol
timeFrame: Change from baseline level at 12-months
measure: Change in Fasting High-Density Lipoprotein (HDL) Cholesterol
timeFrame: Change from baseline level at 12-months
measure: Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol
timeFrame: Change from baseline level at 12-months
measure: Change in Fasting Triglycerides
timeFrame: Change from baseline level at 12-months
measure: Change in Fasting Glucose
timeFrame: Change from baseline level at 12-months
measure: Change in Systolic Blood Pressure
timeFrame: Change from baseline level at 12-months
measure: Change in Diastolic Blood Pressure (mmHg)
timeFrame: Change from baseline value at 12 months
measure: Change in Physical Function Performance Battery
timeFrame: Change from baseline score at 12-months
measure: Change in Physical Activity Minutes/Week Using All CHAMPS Items
timeFrame: Change from baseline minutes/week at 12-months
measure: Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week
timeFrame: percentage reporting higher intensity level activities 3 times per week or more at 12 months
measure: Change in Health Related Quality of Life-physical Component Summary Score
timeFrame: Change from baseline score at 12-months
measure: Change in Nutrition
timeFrame: change from baseline score at 12-months
measure: Change in Mood
timeFrame: change from baseline score at 12-months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth M Venditti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.