NCT04633941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 12, 2020

Last Update Submit

November 18, 2020

Conditions

Diabetes Mellitus, Type 2Obesity, MorbidBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Blood Sugar Control

    June2020-July 2020

  • Medical Adherence

    June 2020-July2020

  • Stress level

    June 2020-July2020

  • Physical Activity Level

    June2020-July 2020

Study Arms (2)

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

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

Interventions

Standard CareOTHER

Standard Care

Medical Weight ManagementPost Bariatric Surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Obesity (BMI 30 kg/m2 and above)
  • English literate
  • Mental capacity to make their own decisions

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity, Morbid

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Chin Hong Lim, FRCS

    Staff

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

June 1, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)