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

NCT02977884 | Completed

• 1 other identifier: 12X81
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Hypertension; Dyslipidemias; Overweight and Obesity

Keywords

nutrition; exercise; stress; cardiovascular disease; diabetes; hypertension; dyslipidemia; cholesterol; overweight; obesity; lifestyle

Outcome Measures

Primary Outcomes (1)

• Healthcare expenses

  Healthcare costs

  2.5 years

Secondary Outcomes (4)

• Weight

  3 months

• Fasting Glucose

  3 months

• Fasting Lipid Profile

  3 months

• Absenteeism: Sick days on record at Ohio University Human Resources

  2.5 years

Study Arms (1)

The Complete Health Improvement Program

EXPERIMENTAL

Participants in The Complete Health Improvement Program

Behavioral: The Complete Health Improvement Program

Interventions

The Complete Health Improvement Program 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.

Also known as: CHIP

The Complete Health Improvement Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Under the age of 18

Sponsors & Collaborators

• Ohio University: lead
• Touro University: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (4)

• 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.

  PMID: 21944675 BACKGROUND

• 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.

  PMID: 26830523 BACKGROUND

• 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.

  PMID: 26618437 BACKGROUND

• 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.

  PMID: 24527219 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Hypertension; Dyslipidemias; Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Lipid Metabolism Disorders; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• David S Drozek, DO

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 30, 2016
• Study Start: August 1, 2012
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)