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

Primary Purpose

Cardiovascular Diseases, Diabetes Mellitus, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Complete Health Improvement Program
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring nutrition, exercise, stress, cardiovascular disease, diabetes, hypertension, dyslipidemia, cholesterol, overweight, obesity, lifestyle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ohio University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Complete Health Improvement Program

Arm Description

Participants in The Complete Health Improvement Program

Outcomes

Primary Outcome Measures

Healthcare expenses
Healthcare costs

Secondary Outcome Measures

Weight
Fasting Glucose
Fasting Lipid Profile
Absenteeism: Sick days on record at Ohio University Human Resources

Full Information

First Posted
November 18, 2016
Last Updated
April 4, 2023
Sponsor
Ohio University
Collaborators
Touro University
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1. Study Identification

Unique Protocol Identification Number
NCT02977884
Brief Title
Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project
Official Title
Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University
Collaborators
Touro University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Dyslipidemias, Overweight and Obesity
Keywords
nutrition, exercise, stress, cardiovascular disease, diabetes, hypertension, dyslipidemia, cholesterol, overweight, obesity, lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
389 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Complete Health Improvement Program
Arm Type
Experimental
Arm Description
Participants in The Complete Health Improvement Program
Intervention Type
Behavioral
Intervention Name(s)
The Complete Health Improvement Program
Other Intervention Name(s)
CHIP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healthcare expenses
Description
Healthcare costs
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Weight
Time Frame
3 months
Title
Fasting Glucose
Time Frame
3 months
Title
Fasting Lipid Profile
Time Frame
3 months
Title
Absenteeism: Sick days on record at Ohio University Human Resources
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Drozek, DO
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21944675
Citation
Rankin P, Morton DP, Diehl H, Gobble J, Morey P, Chang E. Effectiveness of a volunteer-delivered lifestyle modification program for reducing cardiovascular disease risk factors. Am J Cardiol. 2012 Jan 1;109(1):82-6. doi: 10.1016/j.amjcard.2011.07.069. Epub 2011 Sep 23.
Results Reference
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PubMed Identifier
26830523
Citation
Leibold C, Shubrook JH, Nakazawa M, Drozek D. Effectiveness of the Complete Health Improvement Program in Reducing Risk Factors for Cardiovascular Disease in an Appalachian Population. J Am Osteopath Assoc. 2016 Feb;116(2):84-91. doi: 10.7556/jaoa.2016.020.
Results Reference
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PubMed Identifier
26618437
Citation
Vogelgesang J, Drozek D, Nakazawa M, Shubrook JH. Payer source influence on effectiveness of lifestyle medicine programs. Am J Manag Care. 2015 Sep 1;21(9):e503-8.
Results Reference
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PubMed Identifier
24527219
Citation
Drozek D, Diehl H, Nakazawa M, Kostohryz T, Morton D, Shubrook JH. Short-term effectiveness of a lifestyle intervention program for reducing selected chronic disease risk factors in individuals living in rural appalachia: a pilot cohort study. Adv Prev Med. 2014;2014:798184. doi: 10.1155/2014/798184. Epub 2014 Jan 16.
Results Reference
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Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project

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