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

Sponsor

Ohio University (Other)

Overall Status

Completed

CT.gov ID

NCT03025451

Collaborator

(none)

512

Enrollment

Location

Arm

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Diabetes Mellitus Hypertension Dyslipidemias Overweight and Obesity	Behavioral: The Complete Health Improvement Program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

512 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: CHIP

Arm

Intervention/Treatment

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 Names:

CHIP

Outcome Measures

Primary Outcome Measures

Weight [4 months]
Weight

Secondary Outcome Measures

Blood Pressure [4 months]
Blood Pressure
Fasting Lipid Profile [4 months]
Fasting Lipid Profile
Fasting Glucose [4 months]
Fasting Glucose

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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