NCT03025451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

4.6 years

First QC Date

January 16, 2017

Last Update Submit

October 31, 2018

Conditions

Keywords

nutritionexercisestressgenderagecommunity supportcardiovascular diseasediabeteshypertensiondyslipidemiacholesteroloverweightobesitylifestyle

Outcome Measures

Primary Outcomes (1)

  • Weight

    Weight

    4 months

Secondary Outcomes (3)

  • Blood Pressure

    4 months

  • Fasting Lipid Profile

    4 months

  • Fasting Glucose

    4 months

Study Arms (1)

The Complete Health Improvement Program

EXPERIMENTAL

Participants in The Complete Health Improvement Program

Behavioral: The Complete Health Improvement Program

Interventions

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.

Also known as: CHIP
The Complete Health Improvement Program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusHypertensionDyslipidemiasOverweightObesityMotor ActivityCoitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesLipid Metabolism DisordersOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSexual Behavior

Study Officials

  • David S Drozek, DO

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 19, 2017

Study Start

May 1, 2011

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

November 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations