PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles and Health Care

NCT ID: NCT02456090

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2030-07-31

Brief Summary

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The purpose of the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders.

Detailed Description

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The primary objective is to create the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care, which will allow the conduct of patient-centered observational studies on weight across the multiple institutions of the PaTH network. Creating the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care will involve:

1. Recruiting patients with longitudinal weight data in the EHR to participate in the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care
2. Administering surveys to the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care approximately every 6 months to collect patient reported outcomes (PROs)
3. Collecting individual patient health record data into the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care database
4. Identifying potential participants for future research studies.
5. Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.

The secondary objectives are to use the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care to answer patient-centered research questions including:

(1) How do survey response rates, sample demographics and survey responses differ by recruitment technique? (2) What are patients' weight management strategies? How much are health care providers contributing to their weight management approaches? Do these relationships vary by weight status, region, age, sex, or race; (3) What are patients' reasons for seeking bariatric surgery and expectations in terms of weight change?; (4) Among patients seeking bariatric surgery, what proportion with high risk for sleep apnea by survey responses have been evaluated for or diagnosed with this health problem? (5) How does physical activity vary with patients co-morbidity status?

Conditions

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Weight

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age in years (\>= 18 years), at the time of the initial data query
* Height - at least 1 at any time; can be outside 5-year cohort time window
* Weight : Two encounters each with weight within the 5-year cohort time window

Exclusion Criteria

* Deceased
* Not proficient in English
* Already enrolled in the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care in another PaTH institution
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

Geisinger Clinic

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Kathleen McTigue

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen McTigue, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Geisinger

Danville, Pennsylvania, United States

Site Status

Jody McCullough

Hershey, Pennsylvania, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Bramante CT, McTigue KM, Lehmann HP, Clark JM, Rothenberger S, Kraschnewski J, Lent MR, Herring SJ, Conroy MB, McCullough J, Bennett WL. Understanding Primary Care Patients' Self-weighing Habits: Cohort Analysis from the PaTH Clinical Data Research Network. J Gen Intern Med. 2019 Sep;34(9):1775-1781. doi: 10.1007/s11606-019-05153-w. Epub 2019 Jul 16.

Reference Type BACKGROUND
PMID: 31313111 (View on PubMed)

Jain S, Rothenberger SD, Bennett WL, Clark JM, Conroy MB, Herring SJ, Kraschnewski JL, Lent MR, Bramante CT, Cappella N, McTigue KM. Provider Advice and Patient Perceptions on Weight Across Five Health Systems. Am J Prev Med. 2020 Sep;59(3):e105-e114. doi: 10.1016/j.amepre.2020.03.013. Epub 2020 May 21.

Reference Type BACKGROUND
PMID: 32446748 (View on PubMed)

Bennett WL, Bramante CT, Rothenberger SD, Kraschnewski JL, Herring SJ, Lent MR, Clark JM, Conroy MB, Lehmann H, Cappella N, Gauvey-Kern M, McCullough J, McTigue KM. Patient Recruitment Into a Multicenter Clinical Cohort Linking Electronic Health Records From 5 Health Systems: Cross-sectional Analysis. J Med Internet Res. 2021 May 27;23(5):e24003. doi: 10.2196/24003.

Reference Type BACKGROUND
PMID: 34042604 (View on PubMed)

Other Identifiers

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STUDY20110295

Identifier Type: -

Identifier Source: org_study_id

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