Clinical trial NCT04633941: Impact of Social Distancing on Bariatric Versus Non-Surgical Obese Patients During COVID-19 Pandemic
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Obesity, Morbid
Bariatric Surgery Candidate
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Weight
timeFrame: June2020-July2020
Secondary outcomes:
measure: Blood Sugar Control
timeFrame: June2020-July 2020
measure: Medical Adherence
timeFrame: June 2020-July2020
measure: Stress level
timeFrame: June 2020-July2020
measure: Physical Activity Level
timeFrame: June2020-July 2020
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Staff
name: Chin Hong Lim, FRCS
role: PRINCIPAL_INVESTIGATOR
References: