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

NCT04924400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-03-19

Study results available
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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

Interventions

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

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

Sponsors & Collaborators

  • Thomas Morland

    lead OTHER

Principal Investigators

  • Thomas B Morland, MD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-01-10
Completion
2023-01-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04924400 on ClinicalTrials.gov