Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes (CHIP-RCT)

Complete Health Improvement Program to Improve Glycemic Control and Reduce Cost of Care for Geisinger Health Plan Members With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: CHIP Program; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CHIP Program; GHP members randomized to the intervention arm will participate in the CHIP Program.	Behavioral: 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
Active Comparator: Usual Diabetes Care; GHP members assigned to the control arm will receive the routine standard of care for GHP members.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Thomas Morland
• Investigators: Principal Investigator: Thomas B Morland, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2020-0438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No