Inpatient Referral to Comprehensive Weight Management for Patients With Obesity

February 7, 2023 updated by: University of Minnesota
Hospitalized patients with obesity who are not already in CWM (comprehensive weight management), or not comfort care/hospice will be identified by the hospitalists then the study dietitian will consent for the patient for enrollment (and answer any question regarding diet/lifestyle) in the study. The intervention will be a CWM referral at discharge. The outcome will be what percentage of these patients go to the CWM clinic at 6 months. At 6 months, the investigators will also call each participant to get a qualitative idea of the process of inpatient referral and barriers to the CWM clinic visit. Weight loss, starting on anti-obesity medication, bariatric surgery will be assessed as a secondary outcome.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nirjhar Dutta, DO, MS, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 13, 2021

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

March 29, 2021

First Posted (ACTUAL)

March 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • GIM-2020-29448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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