- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04822545
Inpatient Referral to Comprehensive Weight Management for Patients With Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- The investigators will conduct an uncontrolled, one arm interventional study on Adult (≥ 18 years of age) hospitalized patients who have obesity (BMI ≥ 30 kg/m 2 or BMI ≥ 27 kg/m 2 if Asian/South Asian), and after stabilization of their acute medical conditions. Prior to hospital discharge, patients will receive a referral for an outpatient comprehensive weight management clinic, with a message that will be sent to the CWM clinic scheduler. Then the investigators will follow the patients forward for 6 months from hospital discharge to assess primary and secondary outcomes. Also, the investigators will look at a historical control group of hospitalized patients with obesity (age, comorbidity matched) from 2014-2019 (chosen instead of 2020, to avoid any impact of 2020 COVID 19 pandemic) and compare the primary and secondary outcomes. At six months after discharge, patients will receive a phone call from the investigators to ascertain whether they were able to go to the comprehensive weight management clinic and about their experience.
- Hospitalized patients who have decision-making capacity and whose acute medical condition has been stabilized who meet study criteria will be identified by study physician(s) who will look at his/her personal patient list on a regular basis to identify patients who meet enrollment criteria and will refer the patients to the co-investigator who is not directly involved in the patient's care who will then discuss enrollment with patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult (≥ 18 years of age) hospitalized patients who have obesity (BMI ≥ 30 kg/m2 or BMI ≥ 25 kg/m2 if Asian/South Asian)
- Who have decision-making capacity
- Whose acute medical condition has been stabilized.
Exclusion Criteria:
- Patients in the ICU or requiring > 6 LPM of supplemental oxygen
- Patients enrolling in hospice/comfort care
- Patients who are already enrolled in weight management or have undergone previous metabolic / bariatric surgery.
- Non-English speaking patients.
- Pregnant patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Intervention Arm
-Adult (≥ 18 years of age) hospitalized patients who have obesity (BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 if Asian/South Asian), as recorded in the medical chart, who have decision-making capacity and whose acute medical condition has been stabilized. we will exclude patients who are enrolling in hospice/comfort care and the patients who are already enrolled in the CWM clinic. Non-English speaking patients. Patients who have opted out of research in their Epic EHR will be excluded from consideration for participation. |
Patients will receive a referral for outpatient CWM clinic, with a message sent to the CWM clinic scheduler, prior to hospital discharge. At six months after discharge, the patient will receive a phone call from the investigators to ascertain whether they were able to go to the CWM clinic and about their experience. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perform a feasibility study of providing referral to outpatient comprehensive weight management clinic to Inpatients with obesity.
Time Frame: Six months
|
Percentage of patients who are seen in weight management clinic at 6 months from hospital discharge
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of Comprehensive weight managment clinic visits at 6 months.
Time Frame: six month and 12 month
|
six month and 12 month
|
|
Weight loss at 6 months from hospital discharge.
Time Frame: six month and 12 month
|
six month and 12 month
|
|
Qualitative information about the experience of getting referral for outpatient weight management while inpatient and experience of going to weight management
Time Frame: six month and 12 month
|
Obtained by survey and phone call
|
six month and 12 month
|
Percentage of patients receiving weight-loss medications or being referred for bariatric surgery.
Time Frame: six month and 12 month
|
six month and 12 month
|
|
Compare primary and secondary outcomes with a historical control of patients with obesity
Time Frame: six month and 12 month
|
Historical control will be defined as inpatients with obesity admitted to the same hospital from 2014 to 2019
|
six month and 12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nirjhar Dutta, DO, MS, University of Minnesota
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIM-2020-29448
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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