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

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ClinicalTrials.gov Identifier: NCT04633941
Recruitment Status : Completed
First Posted : November 18, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Obesity, Morbid Bariatric Surgery Candidate 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

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Study Type : Observational
Actual Enrollment : 272 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : July 30, 2020


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Blood Sugar Control [ Time Frame: June2020-July 2020 ]
    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.

  2. Medical Adherence [ Time Frame: June 2020-July2020 ]
    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.

  3. Stress level [ Time Frame: June 2020-July2020 ]
    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.

  4. Physical Activity Level [ Time Frame: June2020-July 2020 ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633941


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Chin Hong Lim, FRCS Staff
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04633941    
Other Study ID Numbers: HenryLew
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Obesity, Morbid
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight