Clinical trial NCT03025451: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 512
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight
timeFrame: 4 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 4 months
measure: Fasting Lipid Profile
timeFrame: 4 months
measure: Fasting Glucose
timeFrame: 4 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: David S Drozek, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.