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

October 31, 2018 updated by: David Drozek, Ohio University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

512

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 4 months
Weight
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 4 months
Blood Pressure
4 months
Fasting Lipid Profile
Time Frame: 4 months
Fasting Lipid Profile
4 months
Fasting Glucose
Time Frame: 4 months
Fasting Glucose
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16X44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on The Complete Health Improvement Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe