Type 2 DiabetesCHIP-RCTNCT04924400

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

A study testing CHIP Program in people with Type 2 Diabetes, run by Thomas Morland at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: CHIP Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 9 Mar 2022to 10 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger
Danville, Pennsylvania, 17822

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: CHIP Program, Usual Care
Keywords: Type 2 Diabetes
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHIP ProgramBehavioural
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 CareBehavioural
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

Study groups in NCT04924400
Study group	Role	What they receive
CHIP Program	Active comparator	GHP members randomized to the intervention arm will participate in the CHIP Program. Receives: Behavioral: CHIP Program
Usual Diabetes Care	Active comparator	GHP members assigned to the control arm will receive the routine standard of care for GHP members. Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
Change in HbA1c after 6 months compared to baseline
Measured: 6 months
Percentage of Patients Who Completed Biomarkers
What percentage of individuals completed biomarkers
Measured: 3 and 6 months
Percentage of Patients Who Completed Biometrics
What percentage of individuals completed biometrics
Measured: 3 and 6 months
Percentage of Patients Contacted Who Agreed to Participate
What percentage of individuals contacted who agreed to participate in the study
Measured: Baseline

Secondary outcomes (13)

HbA1c Control at 3 Months
Change in HbA1c percentage at 3 months compared to at baseline
Measured: 3 months
LDL-C at 3 Months
Change in LDL-C levels at 3 compared to baseline
Measured: 3 months
Change in Weight at 3 Months
Change in weight at 3 months compared to baseline
Measured: 3months
Change in Weight at 6 Months
Change in weight at 6 months compared to baseline
Measured: 6 months
Health Behaviors, as Measured by CHIP Participation
Overall program completion, defined as completing the majority of study activities
Measured: 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).
Measured: 6 months
Change in LDL-C at 6 Months
Change in LDL-C at 6 months compared to baseline
Measured: 6 months
Systolic Blood Pressure After 3 Months
Change in systolic blood pressure at 3 months compared to baseline
Measured: 3 months
Systolic Blood Pressure at 6 Months
Change in systolic blood pressure at 6 months compared to baseline
Measured: 6 months
Diastolic Blood Pressure at 6 Months
Change in diastolic blood pressure at 6 months compared to baseline
Measured: 6 months
Diastolic Blood Pressure After 3 Months
Change in diastolic blood pressure at 3 months compared to baseline
Measured: 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
Measured: 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
Measured: 6 months beginning with first day of intervention versus 6 months leading up to that day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202210 Jan 2023

First posted14 Jun 2021
Study start9 Mar 2022
Primary completion10 Jan 2023
Study completion10 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04924400
Sponsor's protocol ID: 2020-0438
Acronym: CHIP-RCT
Status last verified: Mar 2025
First submitted: 20 May 2021
Last updated: 19 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Morland T, McNally R, VanEnkevort E, Wilk T, Persing J, Schulze A, Blessing K, Packer S, Kirchner HL. Effects of a hybrid online/in-person implementation of the complete health improvement program on biomarkers, biometrics, and drug utilization in type 2 diabetes mellitus: a pilot randomized-controlled trial. Pilot Feasibility Stud. 2026 Apr 28;12(1):80. doi: 10.1186/s40814-026-01828-4.
PubMed 42046151

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Complete Health Improvement Program to Improve Glycemic Control and Reduce Cost of Care for Geisinger Health Plan Members With Type 2 Diabetes
ClinicalTrials.gov ID: NCT04924400
Acronym / sponsor ID: CHIP-RCT / 2020-0438
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Thomas MorlandUniversity, hospital or other
Study start: 9 Mar 2022 (actual)
Primary completion: 10 Jan 2023 (actual)
Study completion: 10 Jan 2023 (actual)
First posted: 14 Jun 2021 (actual)
Results: Posted 19 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CHIP Program	Active comparator	Behavioral: CHIP ProgramGHP members randomized to the intervention arm will participate in the CHIP Program.
Usual Diabetes Care	Active comparator	Behavioral: Usual CareGHP members assigned to the control arm will receive the routine standard of care for GHP members.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHIP ProgramGHP 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	Behavioural	CHIP Program
Usual CareGHP 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	Behavioural	Usual Diabetes Care

Primary outcome

Change in HbA1c
Time frame: 6 months
Change in HbA1c after 6 months compared to baseline
Percentage of Patients Who Completed Biomarkers
Time frame: 3 and 6 months
What percentage of individuals completed biomarkers
Percentage of Patients Who Completed Biometrics
Time frame: 3 and 6 months
What percentage of individuals completed biometrics
Percentage of Patients Contacted Who Agreed to Participate
Time frame: Baseline
What percentage of individuals contacted who agreed to participate in the study

13 secondary outcomes

HbA1c Control at 3 Months
Time frame: 3 months
LDL-C at 3 Months
Time frame: 3 months
Change in Weight at 3 Months
Time frame: 3months
Change in Weight at 6 Months
Time frame: 6 months
Health Behaviors, as Measured by CHIP Participation
Time frame: 6 months
Number of Diabetes Medications Prescribed at 6 Months
Time frame: 6 months
Change in LDL-C at 6 Months
Time frame: 6 months
Systolic Blood Pressure After 3 Months
Time frame: 3 months
Systolic Blood Pressure at 6 Months
Time frame: 6 months
Diastolic Blood Pressure at 6 Months
Time frame: 6 months
Diastolic Blood Pressure After 3 Months
Time frame: 3 months
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
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

Results and safety

Results posted to the registry on 19 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHIP Program	13	10
Usual Diabetes Care	12	12

Primary outcome: Change in HbA1c

Time frame: 6 months. Mean (95% Confidence Interval). Unit: Percentage of HbA1c

Measure	CHIP Program n = 7	Usual Diabetes Care n = 8
Value	-0.46 (-0.93 to -0.01)	-0.58 (-0.95 to -0.22)

Population analysed: 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.

Primary outcome: Percentage of Patients Who Completed Biomarkers

Time frame: 3 and 6 months. Count of participants. Unit: Participants

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

Population analysed: Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups.

Primary outcome: Percentage of Patients Who Completed Biometrics

Time frame: 3 and 6 months. Count of participants. Unit: Participants

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

Population analysed: Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups.

Primary outcome: Percentage of Patients Contacted Who Agreed to Participate

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Eligible Participants n = 1644
Members called at least once	1087
Unable to reach	690
Did not meet inclusion/exclusion criteria after telephone screening	8
Declined due to transportation issues	53
Declined for another reason	254
Consented to participate in the study	38

Population analysed: 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.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were not tracked for this minimal risk study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Diabetes Care	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): This was a pilot and feasibility study, not powered to answer questions regarding the effect of the intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42046151Morland T, McNally R, VanEnkevort E, Wilk T, Persing J, Schulze A, Blessing K, Packer S, Kirchner HL. Effects of a hybrid online/in-person implementation of the complete health improvement program on biomarkers, biometrics, and drug utilization in type 2 diabetes mellitus: a pilot randomized-controlled trial. Pilot Feasibility Stud. 2026 Apr 28;12(1):80. doi: 10.1186/s40814-026-01828-4.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas B Morland, MD principal investigator

Geisinger Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CHIP Program in people with Type 2 Diabetes, run by Thomas Morland at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04924400, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.