Impact of Social Distancing on Bariatric Versus Non-Surgical Obese Patients During COVID-19 Pandemic

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633941
• Other study ID #: HenryLew
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2020
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Obesity (BMI 30 kg/m2 and above)

• English literate

• Mental capacity to make their own decisions

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus, Type 2
• Obesity, Morbid

Intervention

Other:
• Standard Care
Standard Care

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	1 question asked about participants weight in kg before the lockdown; 1 question asked participants about weight in kg during lockdown	June2020-July2020
Secondary	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.	June2020-July 2020
Secondary	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.	June 2020-July2020
Secondary	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.	June 2020-July2020
Secondary	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	June2020-July 2020