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

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ClinicalTrials.gov Identifier: NCT02977884
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
Touro University
Information provided by (Responsible Party):
David Drozek, Ohio University

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
Cardiovascular Diseases Diabetes Mellitus Hypertension Dyslipidemias Overweight and Obesity Behavioral: The Complete Health Improvement Program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project
Study Start Date : August 2012
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: CHIP




Primary Outcome Measures :
  1. Healthcare expenses [ Time Frame: 2.5 years ]
    Healthcare costs


Secondary Outcome Measures :
  1. Weight [ Time Frame: 3 months ]
  2. Fasting Glucose [ Time Frame: 3 months ]
  3. Fasting Lipid Profile [ Time Frame: 3 months ]
  4. Absenteeism: Sick days on record at Ohio University Human Resources [ Time Frame: 2.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977884


Contacts
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Contact: David S Drozek, DO 678-447-2509 drozek@ohio.edu
Contact: Laura Jensen, MPH 740-593-1136 jensenl@ohio.edu

Locations
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United States, Ohio
Ohio University Recruiting
Athens, Ohio, United States, 45701
Contact: David S Drozek, DO    678-447-2509    drozek@ohio.edu   
Contact: Laura Jensen, MPH    740-593-1136    jensenl@ohio.edu   
Principal Investigator: David S Drozek, DO         
Sponsors and Collaborators
Ohio University
Touro University
Investigators
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Principal Investigator: David S Drozek, DO Ohio University

Publications:
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Responsible Party: David Drozek, Assistant Professor, Ohio University
ClinicalTrials.gov Identifier: NCT02977884     History of Changes
Other Study ID Numbers: 12X81
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Drozek, Ohio University:
cholesterol
nutrition
exercise
stress
cardiovascular disease
diabetes
hypertension
dyslipidemia
overweight
obesity
lifestyle
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Overweight
Cardiovascular Diseases
Vascular Diseases
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases
Iproplatin
Antineoplastic Agents