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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.
This is a pilot prospective randomized-controlled trial of 60 patients randomized to either the intervention group; in which patients enroll in the CHIP program, or the control group, in which patients follow their usual diabetes care. We hypothesize that Geisinger Health Plan 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.
The intervention group will attend 18 classes covering topics such as diet, sleep, exercise instruction, stress management, and toxic substance avoidance. Biometrics (weight, BMI, waist circumference, systolic/diastolic blood pressure), biomarkers (HbA1c, LDL-C) and psychometrics (Wellbeing 360 survey) will be collected on all participants at baseline, 3-months and 6-months.
The CHIP curriculum will be administered during twice weekly 1-hour classes over a 6-week period, followed by weekly 1-hour classes for an additional 6 weeks. The protocol will begin with a 1-month in-person period, with participants subsequently offered the choice between in-person and online attendance for the remaining sessions.
The primary aim is to compare change in HbA1c, LDL-C, systolic blood pressure, body mass index, and waist circumference for GHP members offered CHIP versus members offered standard insurance coverage at 3- and 6-months.
Through this pilot study, we hope to gain insight into whether and how such an application of CHIP could be a cost-effective tool for health plans such as GHP to achieve clinical and financial goals for adult members with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHIP Program | Active Comparator | GHP members randomized to the intervention arm will participate in the CHIP Program. |
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| Usual Diabetes Care | Active Comparator | GHP members assigned to the control arm will receive the routine standard of care for GHP members. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHIP Program | Behavioral | GHP members randomized to the intervention arm will participate in the following activities:
The following data will be collected at weeks 1,12 and 26:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c after 6 months compared to baseline | 6 months |
| Percentage of Patients Who Completed Biomarkers | What percentage of individuals completed biomarkers | 3 and 6 months |
| Percentage of Patients Who Completed Biometrics | What percentage of individuals completed biometrics | 3 and 6 months |
| Percentage of Patients Contacted Who Agreed to Participate | What percentage of individuals contacted who agreed to participate in the study | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Control at 3 Months | Change in HbA1c percentage at 3 months compared to at baseline | 3 months |
| LDL-C at 3 Months | Change in LDL-C levels at 3 compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas B Morland, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42046151 | Derived | Morland T, McNally R, VanEnkevort E, Wilk T, Persing J, Schulze A, Blessing K, Packer S, Kirchner HL. Effects of a hybrid online/in-person implementation of the complete health improvement program on biomarkers, biometrics, and drug utilization in type 2 diabetes mellitus: a pilot randomized-controlled trial. Pilot Feasibility Stud. 2026 Apr 28;12(1):80. doi: 10.1186/s40814-026-01828-4. |
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Participants were randomized to the intervention versus control arms after providing informed consent.
Participants were sent letters and/or electronic portal messages inviting them to participate. Research staff followed up with recruitment phone calls.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHIP Program | GHP members randomized to the intervention arm will participate in the CHIP Program. CHIP Program: GHP members randomized to the intervention arm will participate in the following activities:
The following data will be collected at weeks 1,12 and 26:
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| FG001 | Usual Diabetes Care | GHP members assigned to the control arm will receive the routine standard of care for GHP members. Usual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes. The following data will be collected at weeks 1,12 and 26:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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7 patients randomized to the control group did not attend baseline biomarkers/biometrics; 6 patients in the intervention group did not attend baseline biomarker/biometrics
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| ID | Title | Description |
|---|---|---|
| BG000 | CHIP Program | GHP members randomized to the intervention arm will participate in the CHIP Program. CHIP Program: GHP members randomized to the intervention arm will participate in the following activities:
The following data will be collected at weeks 1,12 and 26:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c | Change in HbA1c after 6 months compared to baseline | Thirty-eight individuals consented to participated in this study. Nineteen were randomized to both the control and intervention groups. Seven intervention and eight control participants provided 6-month biomarkers/biometrics. | Posted | Mean | 95% Confidence Interval | Percentage of HbA1c | 6 months |
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Adverse events were not tracked for this minimal risk study.
There was not formal monitoring for Serious Adverse Events. The study team is not aware of any deaths or serious adverse events among intervention or control participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Diabetes Care | GHP members assigned to the control arm will receive the routine standard of care for GHP members. Usual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes. The following data will be collected at weeks 1,12 and 26:
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This was a pilot and feasibility study, not powered to answer questions regarding the effect of the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Morland | Geisinger | 703-593-0088 | tmorland@geisinger.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2023 | Jun 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care | Behavioral | GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes. The following data will be collected at weeks 1,12 and 26:
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| 3 months |
| Change in Weight at 3 Months | Change in weight at 3 months compared to baseline | 3months |
| Change in Weight at 6 Months | Change in weight at 6 months compared to baseline | 6 months |
| Health Behaviors, as Measured by CHIP Participation | Overall program completion, defined as completing the majority of study activities | 6 months |
| Number of Diabetes Medications Prescribed at 6 Months | Change in number of diabetes medications at 6 months compared to baseline. Number of diabetes medications, by medication class, were collected for each responding patient at 3 and 6 months. Due to small sample size and lack of reversing changes between 3 and 6 months (i.e. all changes made by 3 months were continued at 6-month mark, whereas some additional changes were made between 3 and 6 months), changes between months 1-3 and 4-6 were pooled into a single report of cumulative change between baseline and the 6-month mark). | 6 months |
| Change in LDL-C at 6 Months | Change in LDL-C at 6 months compared to baseline | 6 months |
| Systolic Blood Pressure After 3 Months | Change in systolic blood pressure at 3 months compared to baseline | 3 months |
| Systolic Blood Pressure at 6 Months | Change in systolic blood pressure at 6 months compared to baseline | 6 months |
| Diastolic Blood Pressure at 6 Months | Change in diastolic blood pressure at 6 months compared to baseline | 6 months |
| Diastolic Blood Pressure After 3 Months | Change in diastolic blood pressure at 3 months compared to baseline | 3 months |
| Change in Total Cost of Care, Versus Same 6 Months Year Prior | This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the same 6 months as patient's participation in the study one year prior to enrollment | 6 months of participation compared to same period one year prior |
| Change in Total Cost of Care Versus 6 Months Leading to Intervention | This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the 6 months leading up to that date | 6 months beginning with first day of intervention versus 6 months leading up to that day |
| BG001 | Usual Diabetes Care | GHP members assigned to the control arm will receive the routine standard of care for GHP members. Usual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes. The following data will be collected at weeks 1,12 and 26:
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Usual Diabetes Care | GHP members assigned to the control arm will receive the routine standard of care for GHP members. Usual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes. The following data will be collected at weeks 1,12 and 26:
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| Primary | Percentage of Patients Who Completed Biomarkers | What percentage of individuals completed biomarkers | Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups. | Posted | Count of Participants | Participants | 3 and 6 months |
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| Primary | Percentage of Patients Who Completed Biometrics | What percentage of individuals completed biometrics | Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups. | Posted | Count of Participants | Participants | 3 and 6 months |
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| Primary | Percentage of Patients Contacted Who Agreed to Participate | What percentage of individuals contacted who agreed to participate in the study | A total of 1,644 members were identified for recruitment and a letter was mailed to this group introducing the study. Of those who received a recruitment mailing, 1,087 members received at least one phone call to assess interest in participating in this study. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | HbA1c Control at 3 Months | Change in HbA1c percentage at 3 months compared to at baseline | Posted | Mean | 95% Confidence Interval | Percent | 3 months |
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| Secondary | LDL-C at 3 Months | Change in LDL-C levels at 3 compared to baseline | Nineteen individuals were randomized to each group. Some participants did not return for the 3 and/or 6 month biomarker/biometric collection, resulting in fewer participants being included in the analysis at these timepoints. | Posted | Mean | 95% Confidence Interval | mg/dL | 3 months |
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| Secondary | Change in Weight at 3 Months | Change in weight at 3 months compared to baseline | Posted | Mean | 95% Confidence Interval | Pounds | 3months |
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| Secondary | Change in Weight at 6 Months | Change in weight at 6 months compared to baseline | Posted | Mean | 95% Confidence Interval | Pounds | 6 months |
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| Secondary | Health Behaviors, as Measured by CHIP Participation | Overall program completion, defined as completing the majority of study activities | Participation in at least half of designated study activities | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Diabetes Medications Prescribed at 6 Months | Change in number of diabetes medications at 6 months compared to baseline. Number of diabetes medications, by medication class, were collected for each responding patient at 3 and 6 months. Due to small sample size and lack of reversing changes between 3 and 6 months (i.e. all changes made by 3 months were continued at 6-month mark, whereas some additional changes were made between 3 and 6 months), changes between months 1-3 and 4-6 were pooled into a single report of cumulative change between baseline and the 6-month mark). | Posted | Mean | Full Range | Medications | 6 months |
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| Secondary | Change in LDL-C at 6 Months | Change in LDL-C at 6 months compared to baseline | Posted | Mean | 95% Confidence Interval | mg/dL | 6 months |
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| Secondary | Systolic Blood Pressure After 3 Months | Change in systolic blood pressure at 3 months compared to baseline | Posted | Mean | 95% Confidence Interval | mm Hg | 3 months |
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| Secondary | Systolic Blood Pressure at 6 Months | Change in systolic blood pressure at 6 months compared to baseline | Posted | Mean | 95% Confidence Interval | mm Hg | 6 months |
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| Secondary | Diastolic Blood Pressure at 6 Months | Change in diastolic blood pressure at 6 months compared to baseline | Posted | Mean | 95% Confidence Interval | mm Hg | 6 months |
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| Secondary | Diastolic Blood Pressure After 3 Months | Change in diastolic blood pressure at 3 months compared to baseline | Posted | Mean | 95% Confidence Interval | mm Hg | 3 months |
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| Secondary | Change in Total Cost of Care, Versus Same 6 Months Year Prior | This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the same 6 months as patient's participation in the study one year prior to enrollment | Please note discrepancy between number of patients analyzed and those enrolled/randomized. Individuals randomized to either the intervention or control who completed to study activities (i.e. did not attend any biomarker/biometric collections or CHIP classes) were excluded. Participants in the intervention and control group who gave baseline biomarkers and/or biometrics were included in the cost analyses | Posted | Mean | Standard Deviation | Dollars | 6 months of participation compared to same period one year prior | dollars | dollars |
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| Secondary | Change in Total Cost of Care Versus 6 Months Leading to Intervention | This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the 6 months leading up to that date | Please note discrepancy between number of patients analyzed and those enrolled/randomized. Individuals randomized to either the intervention or control who completed to study activities (i.e. did not attend any biomarker/biometric collections or CHIP classes) were excluded. Participants in the intervention and control group who gave baseline biomarkers and/or biometrics were included in the cost analyses | Posted | Mean | Standard Deviation | Dollars | 6 months beginning with first day of intervention versus 6 months leading up to that day |
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| D004700 | Endocrine System Diseases |
| Provided baseline and 3 month biomarkers only |
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| Provided all biomarkers (baseline, 3-month, 6-month) |
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| Provided baseline and 3 month biometrics only |
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| Provided all biometrics (baseline, 3-month, 6-month) |
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| Did not meet inclusion/exclusion criteria after telephone screening |
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| Declined due to transportation issues |
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| Declined for another reason |
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| Consented to participate in the study |
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