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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Obesity, Morbid; Bariatric Surgery Candidate
• Intervention / Treatment: Other: Standard Care

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 Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity, either post-metabolic surgery (MS) or undergoing active medical management (MM), during the COVID-19 pandemic in Singapore

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Standard Care; 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	Other: Standard Care; Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Chin Hong Lim, FRCS, Staff

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): July 30, 2020

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (ACTUAL): November 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; COVID-19; Diabetes Mellitus, Type 2; Obesity, Morbid
• Other Study ID Numbers: HenryLew

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No