Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALCHIP Program
GHP members randomized to the intervention arm will participate in the following activities: * Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person. * Receive a copy of The Optimal Diet, The Official CHIP Cookbook. The following data will be collected at weeks 1,12 and 26: * Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure * Biomarkers (blood tests): HbA1c, LDL-C * Psychometrics: Wellbeing360 survey
BEHAVIORALUsual 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: * Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure * Biomarkers (blood tests): HbA1c, LDL-C * Psychometrics: Wellbeing360 survey
Sponsors
Thomas Morland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 6 months | Change in HbA1c after 6 months compared to baseline |
| Percentage of Patients Who Completed Biomarkers | 3 and 6 months | What percentage of individuals completed biomarkers |
| Percentage of Patients Who Completed Biometrics | 3 and 6 months | What percentage of individuals completed biometrics |
| Percentage of Patients Contacted Who Agreed to Participate | Baseline | What percentage of individuals contacted who agreed to participate in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Behaviors, as Measured by CHIP Participation | 6 months | Overall program completion, defined as completing the majority of study activities |
| Number of Diabetes Medications Prescribed at 6 Months | 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). |
| Change in LDL-C at 6 Months | 6 months | Change in LDL-C at 6 months compared to baseline |
| Systolic Blood Pressure After 3 Months | 3 months | Change in systolic blood pressure at 3 months compared to baseline |
| HbA1c Control at 3 Months | 3 months | Change in HbA1c percentage at 3 months compared to at baseline |
| Diastolic Blood Pressure at 6 Months | 6 months | Change in diastolic blood pressure at 6 months compared to baseline |
| Diastolic Blood Pressure After 3 Months | 3 months | Change in diastolic blood pressure at 3 months compared to baseline |
| Change in Total Cost of Care, Versus Same 6 Months Year Prior | 6 months of participation compared to same period one 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 |
| Change in Total Cost of Care Versus 6 Months Leading to Intervention | 6 months beginning with first day of intervention versus 6 months leading up to that day | 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 |
| Systolic Blood Pressure at 6 Months | 6 months | Change in systolic blood pressure at 6 months compared to baseline |
| LDL-C at 3 Months | 3 months | Change in LDL-C levels at 3 compared to baseline |
| Change in Weight at 3 Months | 3months | Change in weight at 3 months compared to baseline |
| Change in Weight at 6 Months | 6 months | Change in weight at 6 months compared to baseline |
Countries
United States
Participant flow
Recruitment details
Participants were sent letters and/or electronic portal messages inviting them to participate. Research staff followed up with recruitment phone calls.
Pre-assignment details
Participants were randomized to the intervention versus control arms after providing informed consent.
Participants by arm
| Arm | Count |
|---|---|
| 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:
* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.
* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.
The following data will be collected at weeks 1,12 and 26:
* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure
* Biomarkers (blood tests): HbA1c, LDL-C
* Psychometrics: Wellbeing360 survey | 13 |
| 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:
* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure
* Biomarkers (blood tests): HbA1c, LDL-C
* Psychometrics: Wellbeing360 survey | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | CHIP Program | Usual Diabetes Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 7 Participants | 19 Participants |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 9.27 | 60.9 years STANDARD_DEVIATION 12.4 | 57.6 years STANDARD_DEVIATION 11.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change in HbA1c
Change in HbA1c after 6 months compared to baseline
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Change in HbA1c | -0.46 Percentage of HbA1c |
| Usual Diabetes Care | Change in HbA1c | -0.58 Percentage of HbA1c |
Primary
Percentage of Patients Contacted Who Agreed to Participate
What percentage of individuals contacted who agreed to participate in the study
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHIP Program | Percentage of Patients Contacted Who Agreed to Participate | Members called at least once | 1087 Participants |
| CHIP Program | Percentage of Patients Contacted Who Agreed to Participate | Unable to reach | 690 Participants |
| CHIP Program | Percentage of Patients Contacted Who Agreed to Participate | Did not meet inclusion/exclusion criteria after telephone screening | 8 Participants |
| CHIP Program | Percentage of Patients Contacted Who Agreed to Participate | Declined due to transportation issues | 53 Participants |
| CHIP Program | Percentage of Patients Contacted Who Agreed to Participate | Declined for another reason | 254 Participants |
| CHIP Program | Percentage of Patients Contacted Who Agreed to Participate | Consented to participate in the study | 38 Participants |
Primary
Percentage of Patients Who Completed Biomarkers
What percentage of individuals completed biomarkers
Time frame: 3 and 6 months
Population: Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHIP Program | Percentage of Patients Who Completed Biomarkers | Provided all biomarkers (baseline, 3-month, 6-month) | 8 Participants |
| CHIP Program | Percentage of Patients Who Completed Biomarkers | Consented to participate but did not attend baseline biomarkers | 6 Participants |
| CHIP Program | Percentage of Patients Who Completed Biomarkers | Provided baseline biomarkers but no further biomarkers | 3 Participants |
| CHIP Program | Percentage of Patients Who Completed Biomarkers | Provided baseline and 3 month biomarkers only | 2 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biomarkers | Provided baseline and 3 month biomarkers only | 0 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biomarkers | Provided all biomarkers (baseline, 3-month, 6-month) | 12 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biomarkers | Provided baseline biomarkers but no further biomarkers | 0 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biomarkers | Consented to participate but did not attend baseline biomarkers | 7 Participants |
Primary
Percentage of Patients Who Completed Biometrics
What percentage of individuals completed biometrics
Time frame: 3 and 6 months
Population: Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHIP Program | Percentage of Patients Who Completed Biometrics | Consented to participate but did not provide baseline biometrics | 6 Participants |
| CHIP Program | Percentage of Patients Who Completed Biometrics | Provided baseline biometrics but no further biometrics | 3 Participants |
| CHIP Program | Percentage of Patients Who Completed Biometrics | Provided baseline and 3 month biometrics only | 3 Participants |
| CHIP Program | Percentage of Patients Who Completed Biometrics | Provided all biometrics (baseline, 3-month, 6-month) | 7 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biometrics | Provided all biometrics (baseline, 3-month, 6-month) | 12 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biometrics | Consented to participate but did not provide baseline biometrics | 7 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biometrics | Provided baseline and 3 month biometrics only | 0 Participants |
| Usual Diabetes Care | Percentage of Patients Who Completed Biometrics | Provided baseline biometrics but no further biometrics | 0 Participants |
Secondary
Change in LDL-C at 6 Months
Change in LDL-C at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Change in LDL-C at 6 Months | -4.71 mg/dL |
| Usual Diabetes Care | Change in LDL-C at 6 Months | -8.58 mg/dL |
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
Time frame: 6 months beginning with first day of intervention versus 6 months leading up to that day
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHIP Program | Change in Total Cost of Care Versus 6 Months Leading to Intervention | 1174 Dollars | Standard Deviation 5001 |
| Usual Diabetes Care | Change in Total Cost of Care Versus 6 Months Leading to Intervention | -97 Dollars | Standard Deviation 1628 |
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
Time frame: 6 months of participation compared to same period one year prior
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHIP Program | Change in Total Cost of Care, Versus Same 6 Months Year Prior | -859 Dollars | Standard Deviation 12161 |
| Usual Diabetes Care | Change in Total Cost of Care, Versus Same 6 Months Year Prior | 1303 Dollars | Standard Deviation 2870 |
Secondary
Change in Weight at 3 Months
Change in weight at 3 months compared to baseline
Time frame: 3months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Change in Weight at 3 Months | -5.15 Pounds |
| Usual Diabetes Care | Change in Weight at 3 Months | -2.22 Pounds |
Secondary
Change in Weight at 6 Months
Change in weight at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Change in Weight at 6 Months | -7.38 Pounds |
| Usual Diabetes Care | Change in Weight at 6 Months | -2.10 Pounds |
Secondary
Diastolic Blood Pressure After 3 Months
Change in diastolic blood pressure at 3 months compared to baseline
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Diastolic Blood Pressure After 3 Months | 0.40 mm Hg |
| Usual Diabetes Care | Diastolic Blood Pressure After 3 Months | -4.83 mm Hg |
Secondary
Diastolic Blood Pressure at 6 Months
Change in diastolic blood pressure at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Diastolic Blood Pressure at 6 Months | 1.13 mm Hg |
| Usual Diabetes Care | Diastolic Blood Pressure at 6 Months | -1.00 mm Hg |
Secondary
HbA1c Control at 3 Months
Change in HbA1c percentage at 3 months compared to at baseline
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | HbA1c Control at 3 Months | -0.92 Percent |
| Usual Diabetes Care | HbA1c Control at 3 Months | -0.58 Percent |
Secondary
Health Behaviors, as Measured by CHIP Participation
Overall program completion, defined as completing the majority of study activities
Time frame: 6 months
Population: Participation in at least half of designated study activities
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHIP Program | Health Behaviors, as Measured by CHIP Participation | 9 Participants |
| Usual Diabetes Care | Health Behaviors, as Measured by CHIP Participation | 12 Participants |
Secondary
LDL-C at 3 Months
Change in LDL-C levels at 3 compared to baseline
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | LDL-C at 3 Months | -4.11 mg/dL |
| Usual Diabetes Care | LDL-C at 3 Months | -8.58 mg/dL |
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).
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Number of Diabetes Medications Prescribed at 6 Months | -0.11 Medications |
| Usual Diabetes Care | Number of Diabetes Medications Prescribed at 6 Months | 0.50 Medications |
Secondary
Systolic Blood Pressure After 3 Months
Change in systolic blood pressure at 3 months compared to baseline
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Systolic Blood Pressure After 3 Months | -4.50 mm Hg |
| Usual Diabetes Care | Systolic Blood Pressure After 3 Months | -16.00 mm Hg |
Secondary
Systolic Blood Pressure at 6 Months
Change in systolic blood pressure at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHIP Program | Systolic Blood Pressure at 6 Months | 4.13 mm Hg |
| Usual Diabetes Care | Systolic Blood Pressure at 6 Months | -4.83 mm Hg |