N/A
N=25
Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04924400 ↗Enrolled (actual)
25
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Change in HbA1c — -0.46; -0.58 Percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHIP Program (Behavioral); Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Morland
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-0.46; -0.58 | — |
| PRIMARY Percentage of Patients Who Completed Biomarkers |
6; 7; 3; 0; 2; 0 | — |
| PRIMARY Percentage of Patients Who Completed Biometrics |
6; 7; 3; 0; 3; 0 | — |
| PRIMARY Percentage of Patients Contacted Who Agreed to Participate |
1087; 690; 8; 53; 254; 38 | — |
| SECONDARY HbA1c Control at 3 Months |
-0.92; -0.58 | — |
| SECONDARY LDL-C at 3 Months |
-4.11; -8.58 | — |
| SECONDARY Change in Weight at 3 Months |
-5.15; -2.22 | — |
| SECONDARY Change in Weight at 6 Months |
-7.38; -2.10 | — |
| SECONDARY Health Behaviors, as Measured by CHIP Participation |
9; 12 | — |
| SECONDARY Number of Diabetes Medications Prescribed at 6 Months |
-0.11; 0.50 | — |
| SECONDARY Change in LDL-C at 6 Months |
-4.71; -8.58 | — |
| SECONDARY Systolic Blood Pressure After 3 Months |
-4.50; -16.00 | — |
| SECONDARY Systolic Blood Pressure at 6 Months |
4.13; -4.83 | — |
| SECONDARY Diastolic Blood Pressure at 6 Months |
1.13; -1.00 | — |
| SECONDARY Diastolic Blood Pressure After 3 Months |
0.40; -4.83 | — |
| SECONDARY Change in Total Cost of Care, Versus Same 6 Months Year Prior |
-859; 1303 | — |
| SECONDARY Change in Total Cost of Care Versus 6 Months Leading to Intervention |
1174; -97 | — |
Summary
The Complete Health Improvement Program (CHIP) is a lifestyle improvement program intended to prevent and/or manage cardiovascular disease, diabetes, and other health conditions. This is a pilot-scale randomized-controlled trial comparing the clinical, utilization, and financial outcomes of adult health plan members with type 2 diabetes mellitus (T2DM) offered CHIP versus those only offered standard health plan coverage. We hypothesize that Geisinger Health Plan (GHP) members with T2DM offered CHIP in addition to standard insurance coverage will have improvement in HbA1c and improvements in other biometrics, biomarkers, psychometrics and utilization/financial outcomes, including LDL-C, systolic blood pressure, body mass index, waist circumference, number of diabetes medications prescribed, Wellbeing360 survey, and total cost of healthcare.
Eligibility Criteria
Inclusion Criteria
- Geisinger Health Plan member for a full year prior to enrollment in the study, with plans to remain covered for a full year after the first study visit
- HbA1c resulted within a year of enrollment in the study
- ≥ 18 years
- Current type 2 diabetes diagnosis
- Living in the five-county region served by the Miller Center (Lycoming, Montour, Northumberland, Snyder and Union) with the ability to arrange their own transportation to the Miller Center in Lewisburg at least 10 times in a 3-month period
- Access to computer, phone, or tablet with sufficient internet to complete program activities.
Exclusion Criteria
- Presence of medical condition requiring specific diet (e.g., Celiac disease, phenylketonuria)
- Presence of medical condition contraindicating participation in CHIP, as determined by the Principal Investigator (e.g. cancer on active treatment)
- Pregnancy or plan to become pregnant within one year
- Inability to give informed consent due to mental or psychiatric impairment
- Participation in the Fresh Food Farmacy program
Data sourced from ClinicalTrials.gov (NCT04924400). 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.