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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04822545
Other study ID # GIM-2020-29448
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2021
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
referral to comprehensive weight management clinic
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.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perform a feasibility study of providing referral to outpatient comprehensive weight management clinic to Inpatients with obesity. Percentage of patients who are seen in weight management clinic at 6 months from hospital discharge Six months
Secondary The number of Comprehensive weight managment clinic visits at 6 months. six month and 12 month
Secondary Weight loss at 6 months from hospital discharge. six month and 12 month
Secondary Qualitative information about the experience of getting referral for outpatient weight management while inpatient and experience of going to weight management Obtained by survey and phone call six month and 12 month
Secondary Percentage of patients receiving weight-loss medications or being referred for bariatric surgery. six month and 12 month
Secondary Compare primary and secondary outcomes with a historical control of patients with obesity Historical control will be defined as inpatients with obesity admitted to the same hospital from 2014 to 2019 six month and 12 month
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