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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Diabetes Mellitus Hypertension Dyslipidemias Overweight and Obesity||Behavioral: The Complete Health Improvement Program||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Healthcare expenses [ Time Frame: 2.5 years ]Healthcare costs
- Weight [ Time Frame: 3 months ]
- Fasting Glucose [ Time Frame: 3 months ]
- Fasting Lipid Profile [ Time Frame: 3 months ]
- Absenteeism: Sick days on record at Ohio University Human Resources [ Time Frame: 2.5 years ]
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
|Contact: David S Drozek, DOemail@example.com|
|Contact: Laura Jensen, MPHfirstname.lastname@example.org|
|United States, Ohio|
|Athens, Ohio, United States, 45701|
|Contact: David S Drozek, DO 678-447-2509 email@example.com|
|Contact: Laura Jensen, MPH 740-593-1136 firstname.lastname@example.org|
|Principal Investigator: David S Drozek, DO|
|Principal Investigator:||David S Drozek, DO||Ohio University|