WeightNCT02456090
PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles and Health Care
An observational study of Weight, run by University of Pittsburgh at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight
- How many people
- 1,500 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2015to Jul 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Geisinger
Danville, Pennsylvania, 17822
Jody McCullough
Hershey, Pennsylvania, 17033
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
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:
- 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
- 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)
- Collecting individual patient health record data into the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care database
- Identifying potential participants for future research studies.
- 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
- Weight
- Medical subject headings
- Body Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for WeightStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Johns Hopkins University, Penn State University, Geisinger Clinic
- Responsible party
- Principal investigator, Kathleen McTigue, University of Pittsburgh
- Investigators
- Kathleen McTigue, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456090
- Sponsor's protocol ID
- STUDY20110295
- Status last verified
- Jun 2026
- First submitted
- 26 May 2015
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31313111Jain 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.
PubMed 32446748Bennett 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.
PubMed 34042604
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles and Health Care
- ClinicalTrials.gov ID
- NCT02456090
- Acronym / sponsor ID
- STUDY20110295
- Conditions
- Weight
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Temple University, Johns Hopkins University, Penn State University, Geisinger Clinic
- Study start
- May 2015
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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
- 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)
- Collecting individual patient health record data into the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care database
- Identifying potential participants for future research studies.
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Create PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care
Time frame: 18 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 31313111Bramante 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.
- Results publication: PubMed 32446748Jain 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.
- Results publication: PubMed 34042604Bennett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen McTigue, MD principal investigator
University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight, run by University of Pittsburgh at 5 sites 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 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Create PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles, Body Weight and Health Care (time frame: 18 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 NCT02456090, which also lists 3 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 11 Jun 2026.