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Cardiovascular DiseasesNCT03025451

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

A study testing The Complete Health Improvement Program in people with Cardiovascular Diseases and Diabetes Mellitus, run by Ohio University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
The Complete Health Improvement Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
512 participants
Where
1 siteUnited States
Study dates
May 2011to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio University

    Athens, Ohio, 45701

Other trials in United States

About this study

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.

Read the 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.

Being tested
The Complete Health Improvement Program
Keywords
nutrition, exercise, stress, gender, age, community support, cardiovascular disease, diabetes, hypertension, dyslipidemia, cholesterol, overweight, obesity, lifestyle
Medical subject headings
Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Dyslipidemias, Overweight, Obesity, Motor Activity, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Complete Health Improvement ProgramBehavioural

    Also called CHIP

    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.

Study groups in NCT03025451
Study groupRoleWhat they receive
The Complete Health Improvement ProgramExperimentalParticipants in The Complete Health Improvement Program
Receives: Behavioral: The Complete Health Improvement Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Weight

    Measured: 4 months

Secondary outcomes (3)

  1. Blood Pressure

    Blood Pressure

    Measured: 4 months

  2. Fasting Lipid Profile

    Fasting Lipid Profile

    Measured: 4 months

  3. Fasting Glucose

    Fasting Glucose

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2017 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03025451
Sponsor's protocol ID
16X44
Status last verified
Oct 2018
First submitted
16 Jan 2017
Last updated
2 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21944675

  • 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.

    PubMed 26830523

  • 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.

    PubMed 26618437

  • 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.

    PubMed 24527219

  • 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.

    PubMed 25476714

Questions about this trial

What is this clinical trial studying?

A study testing The Complete Health Improvement Program in people with Cardiovascular Diseases and Diabetes Mellitus, run by Ohio University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03025451, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.

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Clinical Trial NCT03025451 | AzTrials