ObesityNCT04822545
Inpatient Referral to Comprehensive Weight Management for Patients With Obesity
A study testing referral to comprehensive weight management clinic in people with Obesity, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- referral to comprehensive weight management clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- referral to comprehensive weight management clinic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
referral to comprehensive weight management clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: referral to comprehensive weight management clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months
Secondary outcomes (5)
The number of Comprehensive weight managment clinic visits at 6 months.
Measured: six month and 12 month
Weight loss at 6 months from hospital discharge.
Measured: 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
Obtained by survey and phone call
Measured: six month and 12 month
Percentage of patients receiving weight-loss medications or being referred for bariatric surgery.
Measured: six month and 12 month
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
Measured: six month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start13 May 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirjhar Dutta, DO, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822545
- Sponsor's protocol ID
- GIM-2020-29448
- Status last verified
- Feb 2023
- First submitted
- 22 Dec 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Referral to Comprehensive Weight Management for Patients With Obesity
- ClinicalTrials.gov ID
- NCT04822545
- Acronym / sponsor ID
- GIM-2020-29448
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Other: referral to comprehensive weight management clinic-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| referral to comprehensive weight management clinicPatients 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. | Other | Intervention Arm |
Primary outcome
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
5 secondary outcomes
The number of Comprehensive weight managment clinic visits at 6 months.
Time frame: six month and 12 month
Weight loss at 6 months from hospital discharge.
Time frame: 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
Percentage of patients receiving weight-loss medications or being referred for bariatric surgery.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Nirjhar Dutta, DO, MS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing referral to comprehensive weight management clinic in people with Obesity, run by University of Minnesota at 1 site 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 5 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perform a feasibility study of providing referral to outpatient comprehensive weight management clinic to Inpatients with obesity. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.