NCT02456090

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

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 Progress73%
May 2015Jul 2030

Study Start

First participant enrolled

May 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

15.2 years

First QC Date

May 26, 2015

Last Update Submit

July 21, 2025

Conditions

Weight

Outcome Measures

Primary Outcomes (1)

  • Create PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care

    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 (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.

    18 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential participants for the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care will include patients identified through EHRs at the participating PaTH sites, using the eligibility criteria defined through the PCORnet Obesity Task Force and described below. We aim to recruit as many patients as possible from the target population, with one of the recruitment strategies producing a 50% enrollment rate.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Jody McCullough

Hershey, Pennsylvania, 17033, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • 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.

    PMID: 31313111BACKGROUND

  • 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.

    PMID: 32446748BACKGROUND

  • 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.

    PMID: 34042604BACKGROUND

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen McTigue, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations

US(5)