NCT04822545

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 22, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

December 22, 2020

Last Update Submit

February 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The number of Comprehensive weight managment clinic visits at 6 months.

    six month and 12 month

  • Weight loss at 6 months from hospital discharge.

    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

    six month and 12 month

  • Percentage of patients receiving weight-loss medications or being referred for bariatric surgery.

    six month and 12 month

  • Compare primary and secondary outcomes with a historical control of patients with obesity

    six month and 12 month

Study Arms (1)

Intervention Arm

OTHER

-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.

Other: referral to comprehensive weight management clinic

Interventions

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.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nirjhar Dutta, DO, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

March 30, 2021

Study Start

May 13, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations