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

Sponsor
Ohio University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02977884
Collaborator
Touro University (Other)
200
1
1
293
0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The Complete Health Improvement Program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project
Actual Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Jan 1, 2036
Anticipated Study Completion Date :
Jan 1, 2037

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Healthcare expenses [2.5 years]

      Healthcare costs

    Secondary Outcome Measures

    1. Weight [3 months]

    2. Fasting Glucose [3 months]

    3. Fasting Lipid Profile [3 months]

    4. Absenteeism: Sick days on record at Ohio University Human Resources [2.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio University Athens Ohio United States 45701

    Sponsors and Collaborators

    • Ohio University
    • Touro University

    Investigators

    • Principal Investigator: David S Drozek, DO, Ohio University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David Drozek, Assistant Professor, Ohio University
    ClinicalTrials.gov Identifier:
    NCT02977884
    Other Study ID Numbers:
    • 12X81
    First Posted:
    Nov 30, 2016
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by David Drozek, Assistant Professor, Ohio University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 20, 2022