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

NCT04924400 | Completed Results

• 1 other identifier: 2020-0438
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• HbA1c Control at 3 Months

  3 months

• LDL-C at 3 Months

  3 months

• Change in Weight at 3 Months

  3months

• Change in Weight at 6 Months

  6 months

• Health Behaviors, as Measured by CHIP Participation

  6 months

Study Arms (2)

CHIP Program

ACTIVE COMPARATOR

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

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.

Behavioral: Usual Care

Interventions

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

CHIP Program

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

Usual Diabetes Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Morland: lead

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This was a pilot and feasibility study, not powered to answer questions regarding the effect of the intervention.

Results Point of Contact

• Title: Dr. Thomas Morland
• Organization: Geisinger

tmorland@geisinger.edu

703-593-0088

Study Officials

• Thomas B Morland, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 14, 2021
• Study Start: March 9, 2022
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)