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

Patients and caregivers are asked to complete a questionnaire

Questionnaire

Philip Debruyne, MD, PhD, MSc, FRCP

Cancer and cancer treatments are accompanied by several possible side effects, such as nausea, hot flashes, fatigue, drowsiness, etc. Complementary and integrative therapies, such as acupuncture, could be used to manage these symptoms. The aim of this study for our research team is to have an idea of the interest of cancer patients and caregivers in acupuncture. This is a prospective, interventional study. Cancer patients and caregivers will be approached at the day care clinic by a health care worker to participate in this study. They will be asked to complete a questionnaire about their interest in acupuncture and their motivation, what symptoms they would need it for, where they would like this acupuncture to take place, whether they are willing to pay for it, and whether they would be interested in an information session about acupuncture.

The Interest of Cancer Patients and Caregivers in Acupuncture: a Survey

General Hospital Groeninge

Principal investigator

Mathilde Touvier, Dr

Pilar Galan, Dr

Serge Hercberg, Pr

Emmanuelle Kesse-Guyot, Dr

Sandrine Péneau, Dr

Léopold Fezeu, Dr

Chantal Julia, Dr

Valentina Andreeva, Dr

Allès Benjamin, Dr

Baudry Julia, Dr

Deschasaux Mélanie, Dr

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (\>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.

Samples of serum, plasma, and buffy-coats (for genetic analyses), as well as urine samples was set up for 19 600 subjects of the cohort.

The NutriNet-Santé Study

The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors

self reported though validated scales and/or questionnaires

combination of previsously listed mental and physical health outcomes

Institut National de la Santé Et de la Recherche Médicale, France

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Conservatoire national des Arts et Métiers

University of Paris 13

Blood and Lymph Conditions

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.

Questionnaires

Karen S Jensen, MD

The aim of the study is to evaluate the family perspective on follow-up programs after treatment for childhood acute lymphoblastic leukaemia. It is relevant when new follow-up programs are to be designed.

More than 90 % of paediatric patients with acute lymphoblastic leukaemia (ALL), treated on the Nordic Society of Pediatric Hematology and Oncology (NOPHO) ALL-2008 protocol, are alive five years after diagnosis. The main reason for treatment failure being relapse.

The risk of relapse after treatment for ALL is highest within the first two years after cessation of maintenance therapy. Therefore, it has been routine in most countries to follow-up patients in the outpatient clinic every one or two months during the first years after end of therapy for ALL in order to detect recurrence and possible late sequelae at an early stage.

In children with ALL there are only a few studies on the value of routine follow-up, including haematological status after cessation of maintenance therapy. These studies showed that approximately 90% of the relapses were diagnosed in children with symptoms of leukaemia progression and that routine blood tests and clinical follow-ups were of little value. It is well known that there are other issues besides the risk of relapse, which are relevant for families after cessation of ALL therapy i.e. risk of late effects of treatment, psychosocial problems related to the child's return to "normal" life etc. These issues will also have an impact upon how the follow-up programs are planned. The investigators will study the family perspectives on follow-up during the first 5-years after cessation of maintenance therapy in a Danish cohort of children treated according to the NOPHO ALL-2008 protocol.

The investigators will conduct a cross-sectional study. Outcomes are patient-reported as the measurement instrument used is questionnaires. Eligible families are families with children diagnosed with acute lymphoblastic leukaemia in Denmark and being in the period 0-5 years after cessation of maintenance therapy.

The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives

Self-designed questionnaire. Six items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the six items.

An item evaluating the need for extra visits on a scale 1-3. Higher values represent a worse outcome.

An item evaluating parental reported worries about the future on a scale 1-5. Higher values represent a worse outcome.

Self-designed questionnaire. An item evaluating satisfaction the time interval between visits on a scale 1-3. Higher values represent a worse outcome.

Pediatric Quality of Life Inventory questionnaire (the parent proxy). A validated measure of health-related quality of life.

Self-designed questionnaire. Fifteen items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the fifteen items.

An item evaluating the duration of the time period before the child was able to attend day-care/school on a scale 1-5. Higher values represent a worse outcome.

Self-designed questionnaire. In need of advice between visits what are the strategy of the participants: seeking hospital, general practitioner or postponing till next scheduled visit.

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
The Interest of Cancer Patients and Caregivers in Acupuncture: a Survey	NCT03744299	Cancer	Questionnaire	18 Years -	General Hospital Groeninge
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
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 NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives	NCT03985215	Precursor Cell ... Surveys and Que...	Questionnaires	1 Year - 15 Years	University of Aarhus
The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives	NCT03985215	Precursor Cell ... Surveys and Que...	Questionnaires	1 Year - 15 Years	University of Aarhus

Spots Global Cancer Trial Database for surveys and questionnaires