Diabetes Mellitus, Type 2NCT04633941
Impact of Social Distancing on Bariatric Versus Non-Surgical Obese Patients During COVID-19 Pandemic
An observational study of Diabetes Mellitus, Type 2 and Obesity, Morbid, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
In response to the COVID-19 pandemic, weight management programs and metabolic surgery have been deferred to contain the virus. Quarantine and social distancing negatively impact dietary, exercise and psychological health of obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Morbid, Bariatric Surgery Candidate
- How many people
- 272 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2020to 30 Jul 2020
- Phase
- Observational
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with obesity, either post-metabolic surgery (MS) or undergoing active medical management (MM), during the COVID-19 pandemic in Singapore
Who may be able to join
- Obesity (BMI 30 kg/m2 and above)
- English literate
- Mental capacity to make their own decisions
Who cannot join
- Undergone bariatric surgery ≤ 6 months ago
- Have active eating disorders
- Pregnant or had given birth ≤ 6 months ago
- Admitted to hospital or tested positive for COVID-19
- Exhibit symptoms of active severe psychological and psychiatric conditions like psychosis, self-harm, suicide, hallucinations that may hinder them from providing accurate responses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Impact of Social Distancing and Lockdown on Bariatric Patients Versus Non-Surgical Obese Patients During COVID-19 Pandemic - Cross Sectional Study
In response to the COVID-19 pandemic, weight management programs and metabolic surgery have been deferred to contain the virus. Quarantine and social distancing negatively impact dietary, exercise and psychological health of obese individuals. The study aims to evaluate the impact of social distancing measures on post-metabolic surgery patients compare to non-surgical obese patients and discuss potential strategies for management post COVID-19.
Read the detailed description
In Singapore, a nationwide partial lockdown, termed the "circuit breaker" was imposed from 7th April until 1st June 2020 in response to the COVID-19 pandemic (Appendix A). Our study aims to evaluate the impact of social distancing and lockdowns during this circuit breaker period on our patients with obesity, either post-metabolic surgery (MS) or undergoing active medical management (MM), during the COVID-19 pandemic in Singapore. Results will help inform and address the challenges in patient care that this pandemic has brought to light, its long-term implications on the management of the bariatric patient and discuss potential strategies for the management of a bariatric patient in a post COVID-19 society. To the knowledge of this paper, this is the first study to compare the impact of COVID on MS and MM patients which will allow understanding of unique stressors faced by MS patients
This study adopted a cross-sectional survey design to evaluate the impact of lockdown social distancing measures on obese patients in Singapore. The study conducted either face-to-face questionnaires in the clinic after lockdown for those who were not suitable for video consultation or questionnaires administered via telecommunication channels such as WhatsApp
- Being tested
- Standard Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Post Bariatric Surgery | Post Bariatric Surgery more than 6 month. Obesity (BMI 30 kg/m2 and above), English literate and having mental capacity to make their own decisions. Patients were excluded if they had undergone bariatric surgery ≤ 6 months ago, have active eating disorders, are pregnant or had given birth ≤ 6 months ago. Patients who were admitted to hospital or tested positive for COVID-19 were excluded too. Patients who had symptoms of active severe psychological and psychiatric conditions like psychosis, self-harm, suicide, hallucinations were also excluded Receives: Other: Standard Care | |
| Medical Weight Management | Obesity (BMI 30 kg/m2 and above), English literate and having mental capacity to make their own decisions. Patients were excluded if they had undergone bariatric surgery ≤ 6 months ago, have active eating disorders, are pregnant or had given birth ≤ 6 months ago. Patients who were admitted to hospital or tested positive for COVID-19 were excluded too. Patients who had symptoms of active severe psychological and psychiatric conditions like psychosis, self-harm, suicide, hallucinations were also excluded Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
1 question asked about participants weight in kg before the lockdown; 1 question asked participants about weight in kg during lockdown
Measured: June2020-July2020
Secondary outcomes (4)
Blood Sugar Control
Participants were asked 1 question on how well blood sugar was controlled before the lock down. An ordinal scale was used: Very Poor, Poor, Reasonable, Good, Very Good. Participants were asked 1 question on how well blood sugar was controlled during the lock down. An ordinal scale was used: Very Poor, Poor, Reasonable, Good, Very Good.
Measured: June2020-July 2020
Medical Adherence
Participants were asked how often medication was missed before the lockdown with1 question using an ordinal scale: Never, Once in a while, Sometime, Usually, All the Time. Participants were asked how often medication was missed during the lockdown with1 question using an ordinal scale: Never, Once in a while, Sometime, Usually, All the Time.
Measured: June 2020-July2020
Stress level
Participants were asked on the level of stress before the lockdown using a Likert scale of 1-10; with 1=not stressful at all; 10= extremely stressful. Participants were asked level of stress were during the lockdown using a Likert scale of 1-10; with 1=not stressful at all; 10= extremely stressful.
Measured: June 2020-July2020
Physical Activity Level
Participants were asked frequency of exercise before the lockdown on a ordinal scale ranging from less than 1 time a week; Once a week; 2-3 times a week;4-5 times a week; More than 5 times a week. Participants were asked frequency of exercise during the lockdown on a ordinal scale ranging from less than 1 time a week; Once a week; 2-3 times a week;4-5 times a week; More than 5 times a week
Measured: June2020-July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Jun 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin Hong Lim, FRCS, Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633941
- Sponsor's protocol ID
- HenryLew
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- 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 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Impact of Social Distancing and Lockdown on Bariatric Patients Versus Non-Surgical Obese Patients During COVID-19 Pandemic - Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04633941
- Acronym / sponsor ID
- HenryLew
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 18 Nov 2020 (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.
In response to the COVID-19 pandemic, weight management programs and metabolic surgery have been deferred to contain the virus. Quarantine and social distancing negatively impact dietary, exercise and psychological health of obese individuals. The study aims to evaluate the impact of social distancing measures on post-metabolic surgery patients compare to non-surgical obese patients and discuss potential strategies for management post COVID-19.
Detailed description
In Singapore, a nationwide partial lockdown, termed the "circuit breaker" was imposed from 7th April until 1st June 2020 in response to the COVID-19 pandemic (Appendix A). Our study aims to evaluate the impact of social distancing and lockdowns during this circuit breaker period on our patients with obesity, either post-metabolic surgery (MS) or undergoing active medical management (MM), during the COVID-19 pandemic in Singapore. Results will help inform and address the challenges in patient care that this pandemic has brought to light, its long-term implications on the management of the bariatric patient and discuss potential strategies for the management of a bariatric patient in a post COVID-19 society. To the knowledge of this paper, this is the first study to compare the impact of COVID on MS and MM patients which will allow understanding of unique stressors faced by MS patients
This study adopted a cross-sectional survey design to evaluate the impact of lockdown social distancing measures on obese patients in Singapore. The study conducted either face-to-face questionnaires in the clinic after lockdown for those who were not suitable for video consultation or questionnaires administered via telecommunication channels such as WhatsApp
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post Bariatric Surgery | – | Other: Standard CarePost Bariatric Surgery more than 6 month. Obesity (BMI 30 kg/m2 and above), English literate and having mental capacity to make their own decisions. Patients were excluded if they had undergone bariatric surgery ≤ 6 months ago, have active eating disorders, are pregnant or had given birth ≤ 6 months ago. Patients who were admitted to hospital or tested positive for COVID-19 were excluded too. Patients who had symptoms of active severe psychological and psychiatric conditions like psychosis, self-harm, suicide, hallucinations were also excluded |
| Medical Weight Management | – | Other: Standard CareObesity (BMI 30 kg/m2 and above), English literate and having mental capacity to make their own decisions. Patients were excluded if they had undergone bariatric surgery ≤ 6 months ago, have active eating disorders, are pregnant or had given birth ≤ 6 months ago. Patients who were admitted to hospital or tested positive for COVID-19 were excluded too. Patients who had symptoms of active severe psychological and psychiatric conditions like psychosis, self-harm, suicide, hallucinations were also excluded |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity, either post-metabolic surgery (MS) or undergoing active medical management (MM), during the COVID-19 pandemic in Singapore
Key inclusion criteria (3 listed)
- Obesity (BMI 30 kg/m2 and above)
- English literate
- Mental capacity to make their own decisions
Key exclusion criteria (5 listed)
- Undergone bariatric surgery ≤ 6 months ago
- Have active eating disorders
- Pregnant or had given birth ≤ 6 months ago
- Admitted to hospital or tested positive for COVID-19
- Exhibit symptoms of active severe psychological and psychiatric conditions like psychosis, self-harm, suicide, hallucinations that may hinder them from providing accurate responses.
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 |
|---|---|---|
| Standard CareStandard Care | Other | Medical Weight Management, Post Bariatric Surgery |
Primary outcome
Weight
Time frame: June2020-July2020
1 question asked about participants weight in kg before the lockdown; 1 question asked participants about weight in kg during lockdown
4 secondary outcomes
Blood Sugar Control
Time frame: June2020-July 2020
Medical Adherence
Time frame: June 2020-July2020
Stress level
Time frame: June 2020-July2020
Physical Activity Level
Time frame: June2020-July 2020
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 20 Nov 2020.
- 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.
Chin Hong Lim, FRCS principal investigator
Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Obesity, Morbid, run by Singapore General Hospital at 1 site in Singapore.
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 20 Nov 2020. 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 Singapore. 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?
Weight (time frame: June2020-July2020). 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 20 Nov 2020.