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OpenTrials
Completed

NCT Number: NCT03025451

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

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Body Weight Coitus Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CHIP

Primary outcomes

  1. Weight

    Time frame: 4 months

    Weight

Secondary outcomes

  1. Blood Pressure

    Time frame: 4 months

    Blood Pressure

  2. Fasting Lipid Profile

    Time frame: 4 months

    Fasting Lipid Profile

  3. Fasting Glucose

    Time frame: 4 months

    Fasting Glucose

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jan 19, 2017
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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