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

NCT ID: NCT04924400

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-01-10

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CHIP Program

GHP members randomized to the intervention arm will participate in the CHIP Program.

Group Type: ACTIVE_COMPARATOR

CHIP Program

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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:

• Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure
• Biomarkers (blood tests): HbA1c, LDL-C
• Psychometrics: Wellbeing360 survey

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Geisinger Health Plan member for a full year prior to enrollment in the study, with plans to remain covered for a full year after the first study visit
• HbA1c resulted within a year of enrollment in the study
• ≥ 18 years
• Current type 2 diabetes diagnosis
• Living in the five-county region served by the Miller Center (Lycoming, Montour, Northumberland, Snyder and Union) with the ability to arrange their own transportation to the Miller Center in Lewisburg at least 10 times in a 3-month period
• Access to computer, phone, or tablet with sufficient internet to complete program activities.

Exclusion Criteria

• Presence of medical condition requiring specific diet (e.g., Celiac disease, phenylketonuria)
• Presence of medical condition contraindicating participation in CHIP, as determined by the Principal Investigator (e.g. cancer on active treatment)
• Pregnancy or plan to become pregnant within one year
• Inability to give informed consent due to mental or psychiatric impairment
• Participation in the Fresh Food Farmacy program

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Morland

OTHER

Sponsor Role: lead

Responsible Party

Thomas Morland

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas B Morland, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-0438

Identifier Type: -

Identifier Source: org_study_id