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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04633941
Other study ID # HenryLew
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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