Bariatric Times

MAY 2017

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

Issue link: http://bariatrictimes.epubxp.com/i/824091

Contents of this Issue

Navigation

Page 25 of 28

25 Research Bites Bariatric Times • May 2017 1 80 and 360 days. The evaluation protocol will consist of clinical history, vital signs, neck and waist circumference, clinical analysis of blood inflammatory markers, lung function t ests, maximal ventilatory pressures, full overnight standard polysomnography, excessive daytime sleepiness scale, cardiovascular risk, quality of life and personal satisfaction questionnaires. S tudy Type: Interventional Study Design: Allocation: Randomized I ntervention Model: Parallel Assignment M asking: Outcomes Assessor Primary Purpose: Treatment Eligibility: • Ages Eligible for Study: 18 Years to 65 Years (Adult) • Sexes Eligible for Study: All • Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: -Patients eligible for the trial must c omply with all of the following at randomization: -male and female patients aged 18 to 65 years, -grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities, -awaiting bariatric surgery, -with documented history of conventional weight loss attempts having proven unsuccessful over time, -and if they are able to understand and agreement to participate in the study through a signed term of informed consent. Exclusion Criteria: -Any medical condition rendering surgery too risky; -BMI above 55 kg/m2; -Unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment; -Pregnancy, lactation or planned pregnancy within two years of potential surgical treatment; -Lack of safe access to abdominal cavity or gastrointestinal tract; -Abusive alcohol use or drug use. -Cancer -Any cardiorespiratory condition opposite indicate the surgical procedure. Primary Outcome Measures: • Change in systemic immune response after bariatric surgery. [Time Frame: Baseline immune response to 180 days.] Systemic markers of inflammation through fasting blood samples biochemical indexes. • Change in systemic adipose inflammation response after bariatric surgery. [Time Frame: Baseline adipose inflammation response to 180 days.] Systemic markers of inflammation through biochemical indexes in the visceral (omental, mesenteric) and subcutaneous adipose tissue depots. S econdary Outcome Measures: • Alterations in sleep quality after bariatric surgery. [Time Frame: 180 days] Study sleep patterns through full standard polysomnography. • Changes in pulmonary function after bariatric surgery. [Time Frame: 180 days] Assess pulmonary function through spirometry. • Changes in maximal ventilatory p ressures after bariatric surgery. [Time Frame: 180 days] Assess maximal inspiratory and expiratory pressures through vacuometry. • Changes in health related quality of l ife after bariatric surgery. [Time Frame: 180 days] • Changes in quality of life through Short Form-36 and BAROS questionnaires. S ponsors and Collaborators: • University of Nove de Julho • Irmandade da Santa Casa de Misericordia de Sao Paulo ClinicalTrials.gov Identifier: N CT02409160 MINDFULNESS IN PREPARATION TO BARIATRIC SURGERY (PCONSCIENCE) Status: This study is currently recruiting participants. Purpose: Mindfulness is a common practice already widely used, that has shown benefits in terms of psychological and physical health. It is about learning or learn again to be self present and aware to the environment, across breathing, sensations, emotions and thought centering exercises, in the present moment without any judgement. The goal is to evaluate the efficacy of "mindfulness" versus an active control group in bariatric surgery. Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care Eligibility: • Ages Eligible for Study: 18 Years and older (Adult, Senior) • Sexes Eligible for Study: All • Accepts Healthy Volunteers: No • Criteria Inclusion Criteria: -Adult patients: over 18 years -Patients suffering from morbid obesity (BMI ≥ 40 kg/m²), or severe obesity (BMI ≥ 35 kg/m²) associate with at least a comorbidity likely to be improved by surgery -Patient revised in second-line after the failure of a well conducted medical treatment, nutritional, dietetic and psychotherapeutic during 6 to 12 months : absence of enough weight loss or absence of maintain of weight loss -Absence of any psychiatric counter- argument Exclusion Criteria: -Subjects responding to inclusion criteria of the French National A uthority for Health -Subjects without agoraphobia, or obsessive-compulsive disorder, in post-traumatic stress disorder, alcohol or drugs dependant, without p sychotic disorders, major depressive disorder, or suffering from anti-social personality disorder -Patient registered for social security -Free, signed and informed consent P rimary Outcome Measures: • Psychometric evaluation [Time Frame: About 15 minutes] Tool: SBC- 20 - Scale of Body Connexion • Psychometric evaluation [Time F rame: About 15 minutes] Tool : TAS-20 - The twenty-item Toronto Alexithymia Scale • Psychometric evaluation [Time Frame: 15 minutes] Tool: BAQ-18- B ody Awareness Questionnaire Sponsors and Collaborators: • University Hospital, Grenoble, La Tronche, France ClinicalTrials.gov Identifier: N CT02854306 EXTENSION OF THE 5AS TEAM STUDY FOR IMPROVED PROVIDER OBESITY MANAGEMENT TO PHYSICIANS AND MEDICAL TRAINEES (PART 2) (5AST-MD2) Status: This study is currently recruiting participants. Purpose: Results from the 5As Team (5AsT) Study have identified critical gaps in medical school curricula on obesity, leading to a wave of new family physicians who are unconfident and poorly equipped to manage obesity with their patients. In an effort to address this gap, all first year medical residents training in family medicine at the University of Alberta during the 2015/2016 year will be required to take a 2 day workshop in Obesity Management as part of the Doctor- Patient Relationship Course. The workshop will focus on knowledge, intangible skills and practicing the 5AsT approach to obesity management with patients of all demographics. The objective of the 5AsT MD2 study is to evaluate the impact of this workshop on the residents' attitudes and beliefs about obesity, as well as their level of confidence in using key aspects of the 5As of obesity management to help their patients. Participants will be asked to complete and submit pre- and post- knowledge assessments, narrative reflections and questionnaires assessing their beliefs and attitudes towards people living with obesity as part of their core requirements for the course. For those who consent to participate in the study and release their de-identified course assignments, we will evaluate the impact of the workshop using both quantitative and qualitative methods. The results will assist us in gaining information that may help us improve and further refine curricular materials for physicians and medical trainees. Study Type: Observational Study Design: Observational Model: Case-Only T ime Perspective: Prospective Eligibility: • Ages Eligible for Study: 19 Years and older (Adult, Senior) • Sexes Eligible for Study: All • Accepts Healthy Volunteers: Yes • Sampling Method: Non-Probability Sample Criteria: Inclusion Criteria: - Participants must be first year medical residents training in family medicine at the University of Alberta. They will be recruited from the Obesity Management Workshop that i s a required component of their course on Doctor-Patient Relationships. All participants must be over the age of 18 and be able to communicate effectively in English. E xclusion Criteria: -If participants are unable to communicate effectively in English, they will not be able to participate in the study. The Obesity Management W orkshop will be presented in English and participants must be able to understand the presentation and written documents that they are being asked to complete. Primary Outcome Measures: • Changes in Attitudes Towards Obese Persons (ATOP) [Time Frame: baseline, 3 weeks] Self-reported measure about a person's attitudes towards obese persons to see whether their attitude towards people living with obesity changed as a result of the knowledge gained through the obesity management workshop. • Changes in Beliefs About Obese Persons (BAOP) [Time Frame: baseline, 3 weeks] Self-reported measure about a person's beliefs about obese persons to see whether their beliefs about people living with obesity changed as a result of the knowledge gained through the obesity management workshop. • Changes in Self-Reported Comfort Level (Pre- and Post- Assessment Scale) [Time Frame: baseline, 3 weeks] The pre- and post- questionnaire is a self-reported measure of the resident's comfort level around each of the 5 areas of the 5A's Obesity Management. Questions related to each element of the 5A's are rated using a 5 point Likert Scale. • Qualitative: Narrative Reflections [Time Frame: baseline, 3 weeks] Personal reflection on how the experience and the workshop made the person feel. These will be analyzed using qualitative analysis to see how the workshop may have affected views, beliefs and their practice. Sponsors and Collaborators: • University of Alberta • Alberta Innovates Health Solutions ClinicalTrials.gov Identifier: NCT02648308

Articles in this issue

Links on this page

Archives of this issue

view archives of Bariatric Times - MAY 2017