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Completed

NCT Number: NCT04924400

Complete Health Improvement Program 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHIP Program

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 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:

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

Primary outcomes

  1. Change in HbA1c

    Time frame: 6 months

    Change in HbA1c after 6 months compared to baseline

  2. Percentage of Patients Who Completed Biomarkers

    Time frame: 3 and 6 months

    What percentage of individuals completed biomarkers

  3. Percentage of Patients Who Completed Biometrics

    Time frame: 3 and 6 months

    What percentage of individuals completed biometrics

  4. Percentage of Patients Contacted Who Agreed to Participate

    Time frame: Baseline

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

Secondary outcomes

  1. HbA1c Control at 3 Months

    Time frame: 3 months

    Change in HbA1c percentage at 3 months compared to at baseline

  2. LDL-C at 3 Months

    Time frame: 3 months

    Change in LDL-C levels at 3 compared to baseline

  3. Change in Weight at 3 Months

    Time frame: 3months

    Change in weight at 3 months compared to baseline

  4. Change in Weight at 6 Months

    Time frame: 6 months

    Change in weight at 6 months compared to baseline

  5. Health Behaviors, as Measured by CHIP Participation

    Time frame: 6 months

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

  6. Number of Diabetes Medications Prescribed at 6 Months

    Time frame: 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).

  7. Change in LDL-C at 6 Months

    Time frame: 6 months

    Change in LDL-C at 6 months compared to baseline

  8. Systolic Blood Pressure After 3 Months

    Time frame: 3 months

    Change in systolic blood pressure at 3 months compared to baseline

  9. Systolic Blood Pressure at 6 Months

    Time frame: 6 months

    Change in systolic blood pressure at 6 months compared to baseline

  10. Diastolic Blood Pressure at 6 Months

    Time frame: 6 months

    Change in diastolic blood pressure at 6 months compared to baseline

  11. Diastolic Blood Pressure After 3 Months

    Time frame: 3 months

    Change in diastolic blood pressure at 3 months compared to baseline

  12. Change in Total Cost of Care, Versus Same 6 Months Year Prior

    Time frame: 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

  13. Change in Total Cost of Care Versus 6 Months Leading to Intervention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Thomas Morland

Other

Registry information

Official study title

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

Acronym: CHIP-RCT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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