Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project

April 4, 2023 updated by: David Drozek, Ohio University
The project proposes to provide the Complete Health Improvement Program (CHIP) initially up to 25 adult (non-pregnant) Ohio University employees (and/ or their adult family members) with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension, atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve self-management and the consequences of biometric factors that can be modified by lifestyle changes. The CHIP program is an educationally based, lifestyle intervention program that aims to reduce healthcare cost, absenteeism, and increase employee productivity. The investigators expect that participants following the programs guidelines will lower their body mass index, cholesterol, reduce blood pressure and blood glucose levels, and therefore help to prevent chronic disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In our Western culture, lifestyle changes focusing on diet, exercise and tobacco could prevent about 40% of all cancer deaths, and 82% of cardiac deaths, in the U.S. It is estimated that 71% of colon cancers, 70% of strokes, and 91% of diabetic cases could be avoided by living a healthy lifestyle. These health problems add a tremendous burden to our healthcare budget, and to the loss of productivity of our society. In 2007, it was estimated that 2.3 trillion dollars was spent on healthcare in the U.S., $7,600 for each individual. Expectations are that without dramatic change, this cost will continue to increase to unsustainable levels.

The Complete Health Improvement Program (CHIP) is a community based lifestyle medicine program with proven effectiveness in addressing these problems.

The project proposes to provide the Complete Health Improvement Program (CHIP) to adult (non-pregnant) Ohio University employees (and/ or their adult family members) with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension, atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve self-management and the consequences of biometric factors that can be modified by lifestyle changes. The CHIP program is an educationally based, lifestyle intervention program that aims to reduce healthcare cost, absenteeism, and increase employee productivity. The investigators expect that participants following the programs guidelines will lower their body mass index, cholesterol, reduce blood pressure and blood glucose levels, and therefore help to prevent chronic disease.

Ohio University Human Resources (HR) will provide research participants with scholarships to attend the CHIP program.

One aim of the project is to compare biometrics factors (weight, cholesterol, LDL, HDL, triglycerides, blood pressure, and fasting blood glucose, HgA1c) of participants before and after completion of the program (program completion defined as those who attended at least 14 of 16 CHIP classes, or 15 of the 18 new CHIP+ classes).

A second aim is to compare this groups health claims (health care utilization office visits, emergency room visits, hospitalizations, medication costs) with a control groups data (OU employees who have diabetes / prediabetes, obesity / overweight, hypertension / prehypertension, atherosclerotic cardiovascular disease, or dyslipidemia and do not participate in CHIP program).

A third aim is to compare the treatment groups absenteeism due to illness data with that of the control group.

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult, non-pregnant OU employees or adult families who are covered by Ohio University insurance and are participating in the Athens Complete Health Improvement Program

Exclusion Criteria:

  • Pregnancy
  • Under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Complete Health Improvement Program
Participants in The Complete Health Improvement Program
Behavioral: The Complete Health Improvement Program
CHIP focuses on food, diet, activity, exercise, stress management, by viewing videos, cooking demonstrations, discussion, and exercise. Intervention nurtures intelligent self-care through enhanced understanding of the epidemiology, etiology, and risk factors associated with chronic lifestyle related diseases. The primary focus is the consumption of plant-based whole foods, such as fresh fruits, vegetables, whole grains, legumes, and nuts. The goal was to keep dietary fat below 20% of total calories, daily intake of added sugar below 10 tsps, sodium below 2,000 mg, and cholesterol below 50 mg. High fiber food intake (>35 g/day) is encouraged, and flexibility exercises, a daily walk of 30 minutes or 10,000 steps and daily use of stress management techniques.
Other Names:
  • CHIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare expenses
Time Frame: 2.5 years
Healthcare costs
2.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 3 months
3 months
Fasting Glucose
Time Frame: 3 months
3 months
Fasting Lipid Profile
Time Frame: 3 months
3 months
Absenteeism: Sick days on record at Ohio University Human Resources
Time Frame: 2.5 years
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio University

Collaborators

Touro University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 26, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12X81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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