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

NCT ID: NCT02977884

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2023-04-01

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Diabetes Mellitus Hypertension Dyslipidemias Overweight and Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The Complete Health Improvement Program

Participants in The Complete Health Improvement Program

Group Type EXPERIMENTAL

The Complete Health Improvement Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CHIP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Touro University

OTHER

Sponsor Role collaborator

Ohio University

OTHER

Sponsor Role lead

Responsible Party

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David Drozek

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Drozek, DO

Role: PRINCIPAL_INVESTIGATOR

Ohio University

Locations

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Ohio University

Athens, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21944675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26830523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26618437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24527219 (View on PubMed)

Other Identifiers

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12X81

Identifier Type: -

Identifier Source: org_study_id

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