Trial Outcomes & Findings for Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes (NCT NCT04924400)

NCT ID: NCT04924400

Last Updated: 2025-03-19

Results Overview

Change in HbA1c after 6 months compared to baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-03-19

Participant Flow

Participants were sent letters and/or electronic portal messages inviting them to participate. Research staff followed up with recruitment phone calls.

Participants were randomized to the intervention versus control arms after providing informed consent.

Participant milestones

Measure	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	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
Overall Study STARTED	13	12
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes

Baseline characteristics by cohort

Measure	CHIP Program n=13 Participants 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	Usual Diabetes Care n=12 Participants 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	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	55.1 years STANDARD_DEVIATION 9.27 • n=5 Participants	60.9 years STANDARD_DEVIATION 12.40 • n=7 Participants	57.6 years STANDARD_DEVIATION 11.33 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Change in HbA1c after 6 months compared to baseline

Outcome measures

Measure	CHIP Program n=7 Participants 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	Usual Diabetes Care n=8 Participants 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
Change in HbA1c	-0.46 Percentage of HbA1c Interval -0.93 to -0.01	-0.58 Percentage of HbA1c Interval -0.95 to -0.22

PRIMARY outcome

Timeframe: 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.

What percentage of individuals completed biomarkers

Outcome measures

Measure	CHIP Program n=19 Participants 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	Usual Diabetes Care n=19 Participants 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
Percentage of Patients Who Completed Biomarkers Consented to participate but did not attend baseline biomarkers	6 Participants	7 Participants
Percentage of Patients Who Completed Biomarkers Provided baseline and 3 month biomarkers only	2 Participants	0 Participants
Percentage of Patients Who Completed Biomarkers Provided all biomarkers (baseline, 3-month, 6-month)	8 Participants	12 Participants
Percentage of Patients Who Completed Biomarkers Provided baseline biomarkers but no further biomarkers	3 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

What percentage of individuals completed biometrics

Outcome measures

Measure	CHIP Program n=19 Participants 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	Usual Diabetes Care n=19 Participants 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
Percentage of Patients Who Completed Biometrics Consented to participate but did not provide baseline biometrics	6 Participants	7 Participants
Percentage of Patients Who Completed Biometrics Provided baseline biometrics but no further biometrics	3 Participants	0 Participants
Percentage of Patients Who Completed Biometrics Provided baseline and 3 month biometrics only	3 Participants	0 Participants
Percentage of Patients Who Completed Biometrics Provided all biometrics (baseline, 3-month, 6-month)	7 Participants	12 Participants

PRIMARY outcome

Timeframe: 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.

What percentage of individuals contacted who agreed to participate in the study

Outcome measures

Measure	CHIP Program n=1644 Participants 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	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
Percentage of Patients Contacted Who Agreed to Participate Members called at least once	1087 Participants	—
Percentage of Patients Contacted Who Agreed to Participate Unable to reach	690 Participants	—
Percentage of Patients Contacted Who Agreed to Participate Did not meet inclusion/exclusion criteria after telephone screening	8 Participants	—
Percentage of Patients Contacted Who Agreed to Participate Declined due to transportation issues	53 Participants	—
Percentage of Patients Contacted Who Agreed to Participate Declined for another reason	254 Participants	—
Percentage of Patients Contacted Who Agreed to Participate Consented to participate in the study	38 Participants	—

SECONDARY outcome

Timeframe: 3 months

Change in HbA1c percentage at 3 months compared to at baseline

Outcome measures

Measure	CHIP Program n=10 Participants 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	Usual Diabetes Care n=12 Participants 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
HbA1c Control at 3 Months	-0.92 Percent Interval -1.81 to -0.03	-0.58 Percent Interval -0.95 to -0.22

SECONDARY outcome

Timeframe: 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.

Change in LDL-C levels at 3 compared to baseline

Outcome measures

Measure	CHIP Program n=10 Participants 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	Usual Diabetes Care n=12 Participants 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
LDL-C at 3 Months	-4.11 mg/dL Interval -15.48 to 7.25	-8.58 mg/dL Interval -25.8 to 8.63

SECONDARY outcome

Timeframe: 3months

Change in weight at 3 months compared to baseline

Outcome measures

Measure	CHIP Program n=9 Participants 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	Usual Diabetes Care n=12 Participants 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
Change in Weight at 3 Months	-5.15 Pounds Interval -11.02 to 0.72	-2.22 Pounds Interval -4.86 to 0.42

SECONDARY outcome

Timeframe: 6 months

Change in weight at 6 months compared to baseline

Outcome measures

Measure	CHIP Program n=7 Participants 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	Usual Diabetes Care n=12 Participants 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
Change in Weight at 6 Months	-7.38 Pounds Interval -15.49 to 0.74	-2.10 Pounds Interval -5.69 to 1.49

SECONDARY outcome

Timeframe: 6 months

Population: Participation in at least half of designated study activities

Overall program completion, defined as completing the majority of study activities

Outcome measures

Measure	CHIP Program n=13 Participants 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	Usual Diabetes Care n=12 Participants 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
Health Behaviors, as Measured by CHIP Participation	9 Participants	12 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	CHIP Program n=9 Participants 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	Usual Diabetes Care n=12 Participants 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
Number of Diabetes Medications Prescribed at 6 Months	-0.11 Medications Interval -1.0 to 1.0	0.50 Medications Interval -1.0 to 1.0

SECONDARY outcome

Timeframe: 6 months

Change in LDL-C at 6 months compared to baseline

Outcome measures

Measure	CHIP Program n=8 Participants 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	Usual Diabetes Care n=12 Participants 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
Change in LDL-C at 6 Months	-4.71 mg/dL Interval -20.3 to 10.87	-8.58 mg/dL Interval -25.8 to 8.63

SECONDARY outcome

Timeframe: 3 months

Change in systolic blood pressure at 3 months compared to baseline

Outcome measures

Measure	CHIP Program n=9 Participants 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	Usual Diabetes Care n=12 Participants 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
Systolic Blood Pressure After 3 Months	-4.50 mm Hg Interval -12.54 to 3.54	-16.00 mm Hg Interval -26.02 to -5.98

SECONDARY outcome

Timeframe: 6 months

Change in systolic blood pressure at 6 months compared to baseline

Outcome measures

Measure	CHIP Program n=7 Participants 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	Usual Diabetes Care n=12 Participants 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
Systolic Blood Pressure at 6 Months	4.13 mm Hg Interval -8.89 to 17.14	-4.83 mm Hg Interval -14.46 to 4.79

SECONDARY outcome

Timeframe: 6 months

Change in diastolic blood pressure at 6 months compared to baseline

Outcome measures

Measure	CHIP Program n=7 Participants 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	Usual Diabetes Care n=12 Participants 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
Diastolic Blood Pressure at 6 Months	1.13 mm Hg Interval -4.93 to 7.18	-1.00 mm Hg Interval -5.68 to 3.68

SECONDARY outcome

Timeframe: 3 months

Change in diastolic blood pressure at 3 months compared to baseline

Outcome measures

Measure	CHIP Program n=9 Participants 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	Usual Diabetes Care n=12 Participants 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
Diastolic Blood Pressure After 3 Months	0.40 mm Hg Interval -4.36 to 5.16	-4.83 mm Hg Interval -11.57 to 1.9

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	CHIP Program n=1 dollars 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	Usual Diabetes Care n=1 dollars 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
Change in Total Cost of Care, Versus Same 6 Months Year Prior	-859 Dollars Standard Deviation 12161	1303 Dollars Standard Deviation 2870

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	CHIP Program n=13 Participants 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	Usual Diabetes Care n=12 Participants 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
Change in Total Cost of Care Versus 6 Months Leading to Intervention	1174 Dollars Standard Deviation 5001	-97 Dollars Standard Deviation 1628

Adverse Events

Usual Diabetes Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Morland

Geisinger

Phone: 703-593-0088

Email: tmorland@geisinger.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place