N/A
N=314
Reducing Cardiometabolic Risk and Promoting Functional Health in Older Adults With Obesity and Prediabetes
Obesity · PreDiabetes · Aging
Bottom Line
View on ClinicalTrials.gov: NCT03500640 ↗Enrolled (actual)
314
Serious AEs
1.4%
Results posted
Aug 2024
Primary outcome: Primary: Change in Bodyweight — -7.4; -6.1 percentage of bodyweight change — p=0.196
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DPP Intensive: 30-minute calls (Behavioral); DPP Support: 15-minute calls (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bodyweight |
-4.6; -5.1 | 0.677 |
| PRIMARY Change in Bodyweight |
-4.6; -5.1 | 0.677 |
| PRIMARY Change in Bodyweight |
-4.6; -5.1 | 0.677 |
| SECONDARY Change in Waist Circumference |
-2.2; -2.5 | 0.891 |
| SECONDARY Change in Waist Circumference |
-2.2; -2.5 | 0.891 |
| SECONDARY Change in Fasting Glucose |
-4.2; -4.9 | 0.732 |
| SECONDARY Change in Fasting Glucose |
-4.2; -4.9 | 0.732 |
| SECONDARY Change in Fasting Insulin |
-16.8; -8.5 | 0.521 |
| SECONDARY Change in Fasting Insulin |
-16.8; -8.5 | 0.521 |
| SECONDARY Change in Hemoglobin (HbA1c) |
0.0; 0.1 | 0.778 |
| SECONDARY Change in Hemoglobin (HbA1c) |
0.0; 0.1 | 0.778 |
| SECONDARY Change in Total Cholesterol |
4.1; -7.2 | 0.081 |
| SECONDARY Change in Total Cholesterol |
4.1; -7.2 | 0.081 |
| SECONDARY Change in High-density Lipoprotein (HDL) |
3.5; 4.7 | 0.371 |
| SECONDARY Change in High-density Lipoprotein (HDL) |
3.5; 4.7 | 0.371 |
| SECONDARY Change in Low-density Lipoprotein (LDL) |
1.8; -8.6 | 0.069 |
| SECONDARY Change in Low-density Lipoprotein (LDL) |
1.8; -8.6 | 0.069 |
| SECONDARY Change in Triglycerides |
-5.8; -17.0 | 0.197 |
| SECONDARY Change in Triglycerides |
-5.8; -17.0 | 0.197 |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
0.4; -3.3 | 0.328 |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
0.4; -3.3 | 0.328 |
| SECONDARY Change in Diastolic Blood Pressure (DBP) |
-1.6; -3.7 | 0.288 |
| SECONDARY Change in Diastolic Blood Pressure (DBP) |
-1.6; -3.7 | 0.288 |
| SECONDARY Change in Physical Function |
-0.12; -0.05 | 0.805 |
| SECONDARY Change in Physical Function |
-0.12; -0.05 | 0.805 |
Summary
Obesity and pre-diabetes threatens the overall health and functional independence of older adults but lifestyle weight management for diabetes prevention, soon to be reimbursed by Medicare, can reduce this burden. The current 24-month study will enroll adults, ages 60 and older, through senior community centers and research registries. The investigators will study how two long term weight loss maintenance programs, both using group telephone sessions to support health behavior change, impact meaningful health outcomes. If successful, this project will provide a sustainable intervention model for healthy aging services that can benefit older adults and society.
Eligibility Criteria
Inclusion Criteria
- Men and women
- Ages 60 and older
- Body mass index (BMI) >= 27 kg/m2
- Prediabetes defined as Hemoglobin (HbA1c) >= 5.7 % and = 100 mg/dL and less than 126 mg/dL (at either screening or baseline visit)
- Access to a telephone (for group calls) and to video-player or computer with Internet (to watch session videos and activity videos)
- Able to travel to one of the community clinics in Southwestern Pennsylvania to participate in the first four in-person intervention sessions and five health assessments at 0, 6, 12, 18, and 24 months
- Has health care provider permission to participate
Exclusion Criteria
- Currently diagnosed with diabetes (defined as HbA1c of >= 6.5% at either screening or baseline visit)
- Currently taking glucose lowering medications or weight loss medications
- Weight loss of 9 pounds or more in the last six months
- History of bariatric surgery within the last 2 years
- Permanently confined to wheelchair
- Significant cognitive or psychiatric disability that would preclude participation in normal community-based educational activities
Data sourced from ClinicalTrials.gov (NCT03500640). 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.