Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Immune System Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Obesity

Syndrome

Hypersensitivity

Metabolic Diseases

Weight Loss

Polycystic Ovary Syndrome

Body Weight

Noncommunicable Diseases

Overweight

Overnutrition

Nutrition Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

All patients who participate in the study will be recruited to the Intervention Arm and will undergo the STREAM program, a 24-week weight loss program which includes meal replacement, dietician teaching and regular appointments with their bariatric medicine specialist.

The STREAM program is a 24-week weight-loss program which includes meal replacement, dietician coaching/teaching and weekly visits with a physician.

STREAM program

Judy Shiau, MD

Lesley Ananny, BA

Julie Laroche

The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?

Participants will complete a 24-week weight loss program (STREAM). During this program they will:

* weigh themselves
* complete regular bloodwork and
* fill out a Quality of Life questionnaire at regular intervals

Polycystic ovary syndrome is a common disorder affecting up to 20% of women of reproductive age associated with, but not exclusive to, obesity. Excess weight and especially visceral adiposity lead to increased insulin resistance which in turn will promote decreased SHBG concentrations and excess androgen secretion from the ovaries. Weight-loss is known to improve PCOS symptoms in individuals but threshold of weight-loss needed to achieve improvement in many PCOS outcomes is poorly understood, as is the impact of varied weight-loss strategies employed to promote weight loss.

OBJECTIVE The goal of this study is to understand the effects of increasing weight loss thresholds on multiple PCOS symptoms and features, using a 24-week intensive weight loss program (STREAM) with the possibility of added pharmacotherapy for weight loss when indicated.

RESEARCH QUESTION What is the required weight loss to achieve significant improvement in PCOS outcomes including metabolic, endocrine, fertility and mental health parameters? Is there a difference in outcome improvement from different approaches (meal replacement, adjunct pharmacotherapy), independent from weight-loss?

PRIMARY OUTCOMES

To identify the percentage of bodyweight loss needed to achieve significant improvement in each of the following:

* Endocrine parameters (SHBG, Testosterone, Androstenedione, LH/FSH ratio)
* Insulin sensitivity (HOMA-IR)
* Lipid profile (TG, HDL and Non-HDL levels)
* Liver enzyme profile (ALT)
* Menstrual cyclicity (yes/no)
* Quality of life scale (QOLS-public domain, see annex)

STUDY DESIGN Participants will be recruited from those already referred to the LEAF Clinic. Women over the age of 18 who meet the inclusion criteria will be invited to participate in the STREAM program, a 24-week intensive weight-loss program that includes full and partial meal replacement, dietician group coaching and weekly meetings with a weight-loss specialist physician. The program cost, $2250, will be waived for the purpose of limiting sampling bias as the cost can be untenable for many patients.

DATA COLLECTION Participants will complete PCOS-specific blood tests at the launch of the program, at the end of the 24 weeks and then again at 6 months after the program is finished. They will also be asked to complete the same blood draws at every 5% weight loss from their baseline. Participants will also be asked to complete the Quality of Life Scale (QOLS), a short survey, at the same intervals.

ANTICIPATED RESULTS Learning more about individual variations in outcome improvement with gradual weight loss in a population of women living with PCOS will be helpful in individualizing approaches to weight loss in this population. This study could not only help determine predictors of improvement for each outcome but as well identify weight loss strategies that are more efficient for specific outcomes. This will result in better care for women living with PCOS.

Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group.

Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity

Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity - A Prospective Study Using a Multi-disciplinary Multi-modal Approach to Weight-loss

There is no plan to share IPD with other researchers at this time and we are not seeking permission to do so from our research ethics board.

percentage difference in participant weight

Change in blood test results (SHBG, Testosterone, Androstenedione, LH/FSH ratio) which are all endocrine markers of PCOS

Change in blood test results (HOMA-IR) which is a marker of PCOS

Change in blood test results (TG, HDL and Non-HDL levels) which are markers of PCOS

Change in blood test results (ALT) which is a marker of PCOS

QoLs is a public-domain questionnaire measuring several subjective quality-of-life parameters

LEAF Weight Loss Clinic

Ottawa Hospital Research Institute

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Rare Diseases

Kidney Diseases

Diabetes Mellitus

COVID-19

Hypertension

Respiration Disorders

Respiratory Tract Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Urologic Diseases

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

The intervention of the study is the COVID-19 outbreaks in Hong Kong. The pre-and post-COVID-19 outbreak periods will be defined as 1 January 2010 - 31 December 2019 and 1 January 2020 - 31 December 2024, respectively.

COVID-19 outbreaks

Cindy L.K. Lam, MD

Eric Y.F Wan, PhD

Objectives and aim: To evaluate the long-term spill-over (indirect) effect of Coronavirus disease (COVID-19) on health outcomes and healthcare utilization among people with non-communicable diseases and without COVID-19.

Design: A population-based cohort study using electronic health records of the Hospital Authority (HA) clinical management system, economic modeling, and serial cross-sectional surveys on healthcare service utilization.

Setting: HA public hospitals and outpatient clinics in Hong Kong

Participants: People aged ≥ 18 years with a documented diagnosis of diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic respiratory disease, and chronic kidney disease; without COVID-19; attending HA services between 2010 and 2024.

Main outcome measures: All-cause mortality, disease-specific outcomes, healthcare service utilization, and costs.

Methods: The annual incidence of each outcome in each year between 2010 and 2024 will be calculated. An interrupted time-series analysis to assess the changes in outcomes between pre-and-post-COVID-19 outbreak periods. Long term health economic impact of healthcare disruptions during the COVID-19 outbreak will be modeled using microsimulation. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression to evaluate the effect of different modes of care on the risk of the outcomes.

Implications: Findings will inform policies and practices on contingency care plans to avoid excessive morbidity and mortality and to assure the quality of care for patients with NCD as part of the territorial response to the health crisis.

This study aims to evaluate the spill-over impact of the COVID-19 outbreak on health outcomes, healthcare utilization, and costs in patients with major non-communicable diseases (NCDs). The study will include six leading NCDs (diabetes mellitus, hypertension, cardiovascular diseases (CVD), cancer, chronic kidney diseases (CKD), chronic respiratory diseases) representing the most prevalent conditions and the major causes of deaths in Hong Kong. The objectives of the study are the following:

1. To determine changes in all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the pre-and post- COVID-19 outbreak.
2. To assess the long-term health economic impact of COVID-19 on health outcomes and healthcare utilization rates and costs among major NCD patients by conducting an in-depth economic evaluation
3. To explore the impact of different modes of care on all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the post-COVID-19 period.

This study consists of two study designs.

1. It is a retrospective cohort study using data extracted from the electronic medical records of the Hong Kong Hospital Authority (HA) Clinical Management System (CMS) from 1 January 2010 to 31 December 2024.

   * Anonymous data including socio-demographics, disease-specific parameters identified by International Classification of Primary Care, 2nd edition (ICPC-2) and the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) will be extracted by the Hospital Authority statistics. There will be two phases of data extraction for the data collected in the periods 2010-2021 and 2022-2024.
2. The investigators will carry out two serial cross-sectional surveys on self-reported healthcare service utilization in the second and fourth years after the COVID-19 outbreak.

   * Two surveys will be conducted for patients with the major NCD recruited from outpatient clinics to collect data on healthcare service utilization patterns and rates in the years of 2020 and 2022 using a structured questionnaire.

The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases

The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of Patients With Non-communicable Diseases (and Without COVID-19) : an In-depth Outcome and Health Economic Evaluation

Years of life lost (YLL), quality-adjusted life year (QALY), and disability-adjusted life year (DALY) attributable to delayed care resulting from the COVID-19 outbreak. Based on life expectancy for 10-year ages groups from the Census and Statistics Department life tables for 2017-19.

Incidence of all-cause mortality, and disease-specific complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality) The disease are defined by the diagnosis codes International Classification of Primary Care, Second edition or International Classification of Diseases,Ninth Revision, Clinical Modification.

Utilization rates and costs for public and private healthcare services including hospitalization (episodes, modes of admission and length of stay), specialist and general outpatient consultations (number of visits, modes of consultations, western/Chinese medicine), and Accident \& Emergency Department (AED) attendances (triage urgency level for AED attendances at public hospital).

The University of Hong Kong

Clinical Professor, Chairperson of Department of Family Medicine & Primary Care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity	NCT06325449	Polycystic Ovar... Obesity	STREAM program	18 Years - 99 Years	Ottawa Hospital Research Institute
Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity	NCT06325449	Polycystic Ovar... Obesity	STREAM program	18 Years - 99 Years	Ottawa Hospital Research Institute
The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases	NCT05248412	Diabetes Mellit... Hypertension Cancer Cardiovascular ... Chronic Respira... Kidney Disease,... Noncommunicable...	COVID-19 outbre...	18 Years -	The University of Hong Kong

Spots Global Cancer Trial Database for noncommunicable diseases