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Retrospective Evaluation of Athens Complete Health Improvement Program (CHIP) Database

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, gender, age, community support, cardiovascular disease, diabetes, hypertension, dyslipidemia, cholesterol, overweight, obesity, lifestyle

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Enrolled in The Complete Health Improvement Program
  • Signed the CHIP Request to Participate consent form, which includes the statement: "I understand that my test results are confidential but may be used for statistical analysis and group summaries."
  • Completed both health screens

Exclusion Criteria: none

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

Weight
Weight

Secondary Outcome Measures

Blood Pressure
Blood Pressure
Fasting Lipid Profile
Fasting Lipid Profile
Fasting Glucose
Fasting Glucose

Full Information

First Posted
January 16, 2017
Last Updated
October 31, 2018
Sponsor
Ohio University
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1. Study Identification

Unique Protocol Identification Number
NCT03025451
Brief Title
Retrospective Evaluation of Athens Complete Health Improvement Program (CHIP) Database
Official Title
Retrospective Evaluation of Athens Complete Health Improvement Program (CHIP) Database
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Data from participants in Athens CHIP classes from May 2011 to present will be analyzed to evaluate the differences in outcomes based on: 1) gender, 2) age, 3) whether a household member participated in the class with them. Participants had health screens before and after completing the class. The data from the health screens that will be utilized for comparison will include: body mass index (BMI), blood pressure, and fasting blood sugar and lipid levels.
Detailed Description
Identified data will be provided to the PI from Live Healthy Appalachia/CHIP on a flash drive. This data will be password protected by the research team. The data will consist of two different databases, 1) identifiers with health screen results, 2) identifiers with demographics (age, gender, household member in class). The researchers need data from both databases for this study. Each participant has been assigned a unique participant number by CHIP. The databases will be combined by the research team, allowing the demographics to be matched to the biomarkers. The unique CHIP identifier will be maintained as a participant ID, while all other identifying data will then be deleted from the database. The data will then be analyzed for relationships by a statistician.

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, gender, age, community support, 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
512 (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
Weight
Description
Weight
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Blood Pressure
Time Frame
4 months
Title
Fasting Lipid Profile
Description
Fasting Lipid Profile
Time Frame
4 months
Title
Fasting Glucose
Description
Fasting Glucose
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrolled in The Complete Health Improvement Program Signed the CHIP Request to Participate consent form, which includes the statement: "I understand that my test results are confidential but may be used for statistical analysis and group summaries." Completed both health screens Exclusion Criteria: none
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
result
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
result
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
result
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
result
PubMed Identifier
25476714
Citation
Kent LM, Morton DP, Rankin PM, Mitchell BG, Chang E, Diehl H. Gender differences in effectiveness of the Complete Health Improvement Program (CHIP) lifestyle intervention: an Australasian study. Health Promot J Austr. 2014 Dec;25(3):222-9. doi: 10.1071/HE14041.
Results Reference
result

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Retrospective Evaluation of Athens Complete Health Improvement Program (CHIP) Database

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