N/A
N=322
The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults
Obesity · Cardiovascular Risk Factor · Eating Behavior · Diet Modification · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT03192475 ↗Enrolled (actual)
322
Serious AEs
1.2%
Results posted
Nov 2019
Primary outcome: Primary: Change in Bodyweight — -7.4; -6.1 percent weight change — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GLB plus phone contacts (Behavioral); GLB plus newsletter contacts (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bodyweight |
-7.4; -6.1 | 0.01 sig |
| SECONDARY Change in Waist Circumference |
-5.3; -4.1 | 0.15 |
| SECONDARY Change in Fasting Total Cholesterol |
-5.0; -1.5 | 0.25 |
| SECONDARY Change in Fasting High-Density Lipoprotein (HDL) Cholesterol |
4.8; 2.9 | 0.11 |
| SECONDARY Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol |
-5.8; -1.1 | 0.09 |
| SECONDARY Change in Fasting Triglycerides |
-20.1; -16.5 | 0.53 |
| SECONDARY Change in Fasting Glucose |
-2.3; -1.1 | 0.21 |
| SECONDARY Change in Systolic Blood Pressure |
-2.6; -1.6 | 0.60 |
| SECONDARY Change in Diastolic Blood Pressure (mmHg) |
-3.5; -2.1 | 0.15 |
| SECONDARY Change in Physical Function Performance Battery |
0.3; 0.3 | 0.96 |
| SECONDARY Change in Physical Activity Minutes/Week Using All CHAMPS Items |
30.0; 30.0 | 0.96 |
| SECONDARY Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week |
110; 81 | 0.0009 sig |
| SECONDARY Change in Health Related Quality of Life-physical Component Summary Score |
2.26; 1.11 | 0.18 |
| SECONDARY Change in Nutrition |
1; 1 | 0.34 |
| SECONDARY Change in Mood |
0.65; 0.49 | 0.82 |
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 .
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.
Data sourced from ClinicalTrials.gov (NCT03192475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.